On a typical incoming pack, a buyer sees four different pressure numbers for the same NPWT pump lot. A US hospital sheet copies Medicare's 40-80 mm Hg E2402 wording.1 A clinical protocol or IFU cites about −125 mm Hg.8 A factory quote prints −50 to −450 mmHg in 10 mmHg steps.5 A disposable kit is offered as if the same 40–80 cell applied. Those figures are different cells.
A tender that treats 40–80 mm Hg as the pump's only allowed operating range converts a US DME coding-definition capability window into a clinical ceiling. A tender that copies −50 to −450 mmHg into a Medicare E2402 lot, or treats that envelope as proof of PDAC listing, confuses manufacturer capability with a written Coding Verification Review.12 A52511 remains in force as of 21 September 2026 (Original Effective Date 1 October 2015; Revision Effective Date 15 August 2021; revision history through R9).1 This page is the identity overlay for those cells. It is not a wound-level pressure protocol, not a second lot-by-lot NPWT tender guide, and not a second dressing-kit interchangeability article.
Contents: 1. If a tender copies CMS 40–80 mm Hg, is that an exclusive operating range, a capability window for E2402, or a clinical default? · 2. What does A52511 actually require besides 40–80 mm Hg: continuous and intermittent modes, canister alarms, A6550 and A7000? · 3. Why is PDAC Coding Verification Review a different cell from the 40–80 wording, and why is A9272 not E2402? · 4. How should a buyer read a −125 mm Hg IFU default or a manufacturer −40 to −125 mm Hg guideline without turning this page into a treatment protocol? · 5. When a factory quote prints −50 to −450 mmHg, what does that prove and what does it not prove? · 6. Worked SKUs: VEMERIX NMPA Class II pump Lu Mech Reg. 20182140303 versus a disposable A9272 pump versus an E2402 pump with PDAC listing · 7. Which files sit beside pressure range: OMP / 21 CFR 878.4780, ISO 10079-1 including AMD1:2026, IEC 60601-1-11, and why they are not the 40–80 coding window · 8. Distributor checklist: accept, ask-for-HCPCS-and-PDAC, or send-back-if-40-80-is-exclusive-max-or-if-minus-450-is-sold-as-Medicare · Where VEMERIX fits—and where due diligence still begins · Frequently Asked Questions
If a tender copies CMS 40–80 mm Hg, is that an exclusive operating range, a capability window for E2402, or a clinical default?
When an RFQ lists 'NPWT operating pressure: 40–80 mm Hg' as the only allowed band, the number has usually been lifted from CMS Local Coverage Article A52511.1 Commercial payers reprint it. Aetna CPB 0334 recites that an NPWT pump must be controllable in a range of 40-80 mm Hg subatmospheric pressure.11 Automated summaries then flatten that sentence into a mandatory exclusive range. The live decision is whether 40–80 is an exclusive operating ceiling, a capability window the pump must be able to control, or a clinical default. On A52511's own wording, it is the second.
A52511 defines code E2402 as follows: Code E2402 describes a stationary or portable Negative Pressure Wound Therapy (NPWT) electrical pump which provides controlled sub-atmospheric pressure that is designed for use with NPWT dressings (A6550) and canisters (A7000) to promote wound healing. The NPWT pump must be capable of being selectively switched between continuous and intermittent modes of operation and is controllable to adjust the degree of sub-atmospheric pressure conveyed to the wound in a range of 40-80 mm Hg sub-atmospheric pressure. The system must contain sensors and alarms to monitor pressure variations and exudate volume in the collection canister.1
A pump that is controllable to adjust … in a range of 40-80 mm Hg must be able to control sub-atmospheric pressure in that band. The article does not say 80 mm Hg is the maximum the device may offer, and it does not say 40–80 mm Hg is the clinical default. Treating 40–80 as an exclusive ceiling would conflict with labelled IFU bands that extend beyond 80 mm Hg, including manufacturer guidelines in the −40 to −125 mm Hg range.7 A52511 is a Local Coverage Article, not a statute; the capability reading comes from its grammar, not from a commercial reprint.
40–80 mm Hg is also not the clinical default. Clinic checklists describe modern pumps as commonly capable of settings up to −125 mmHg, with the actual setting tailored to the wound.8 A tender that allows only 40–80 mm Hg as an operating ceiling is no longer writing a coding-capability cell; it is writing a treatment protocol. This page will not do that.
| Instrument / cell | Printed range or gate | What it is | What a tender should not infer |
|---|---|---|---|
| CMS A52511, HCPCS E2402 | 40-80 mm Hg sub-atmospheric, continuous and intermittent, pressure and canister-volume sensors | DME coding-definition capability window | Not an exclusive operating ceiling. Not a clinical default. Not PDAC listing. |
| CMS A52511 PDAC sentence and LCD L33821 | Written Coding Verification Review published on the Product Classification List; undesignated systems denied as not reasonable and necessary | Separate billing and coverage gates | Matching 40–80 wording is not the listing. |
| CMS A52511, HCPCS A9272 | Disposable wound suction; statutorily noncovered as DME | Opposite HCPCS from E2402 | A labelled 40–80 cell does not convert a disposable kit into E2402. |
| FDA 21 CFR 878.4780 / product code OMP | No mmHg band in the regulation or OMP classification | US device-class identity (Class II, 510(k)) | OMP is not proof a named factory SKU is 510(k)-cleared or PDAC-listed. |
| Manufacturer IFU / guideline (example: Smith+Nephew RENASYS) | −40 to −125 mmHg recommended band | Labelled-use guidance for named systems | Not the CMS coding window. Not a tender treatment protocol. |
| VEMERIX NMPA Class II pump (Lu Mech Reg. 20182140303) | −50 to −450 mmHg, 10 mmHg steps, continuous and intermittent | Published manufacturer envelope | Overlaps 50–80 of the CMS window; does not publish 40 mm Hg (−40 mmHg). Not 510(k), PDAC, CE, or a clinical default. |
Source: CMS A52511 and L33821; FDA OMP / 21 CFR 878.4780; Smith+Nephew RENASYS manufacturer guideline; public VEMERIX pump page. Clinical mmHg bands are labelled-use context, not coding law.
What does A52511 actually require besides 40–80 mm Hg: continuous and intermittent modes, canister alarms, A6550 and A7000?
Isolating the 40–80 mm Hg phrase is the other common mistake. A52511's E2402 definition is an integrated-system coding rule, not a lone pressure cell.1 The same paragraph requires:
- Continuous and intermittent modes: the pump must be capable of being selectively switched between continuous and intermittent modes of operation.1 A52511 does not print an on/off cycle such as five minutes on and two minutes off; that timing is not a CMS coding number.
- Controllable 40-80 mm Hg sub-atmospheric pressure: the pump is controllable to adjust the degree of sub-atmospheric pressure conveyed to the wound in that range. The article does not print a display-accuracy tolerance.
- Sensors and alarms: the system must contain sensors and alarms to monitor pressure variations and exudate volume in the collection canister.1 That is the printed gate. Named leak, occlusion, or overheat alarms on a factory datasheet are extra evidence, not additional A52511 headings.
- A6550 dressing sets and A7000 canisters: E2402 is designed for use with NPWT dressings (A6550) and canisters (A7000). A6550 is an allowance for a complete dressing change, including but not limited to non-adherent porous dressing(s), drainage tubing, and occlusive dressing(s). A7000 describes a canister set used with the pump and containing a container to collect wound exudate.1 A52511 does not require a hydrophobic filter by that name.
A52511 also states that NPWT is provided with an integrated system of a pump (E2402), dressing sets (A6550) and a separate collection canister (A7000), and that wound suction systems that do not contain all of the required components are not classified as NPWT.1 Named-pump IFU interchangeability is a different cell, covered in when NPWT dressing kits are not interchangeable across pumps. Lot structure sits in how to specify an NPWT system lot by lot.
Why is PDAC Coding Verification Review a different cell from the 40–80 wording, and why is A9272 not E2402?
Meeting the mechanical sentences in A52511 does not, by itself, let a supplier bill E2402. A52511 prints a separate coding gate: The only products which may be billed using codes E2402 are those for which a written Coding Verification Review has been made by the Pricing, Data Analysis and Coding (PDAC) Contractor and subsequently published on the appropriate Product Classification List.1
LCD L33821 adds a coverage sentence, not the same billing-list sentence: NPWT systems, pumps and their associated supplies, that have not been specifically designated as being qualified to use HCPCS codes E2402 via written instructions from the Pricing, Data Analysis and Coding (PDAC) Contractor will be denied as not reasonable and necessary.2 CMS's MLN compliance tip points suppliers back to those two instruments; it does not replace them.9 This article does not download the live DMECS Product Classification List and does not invent a VEMERIX E2402 row. In a tender, 'PDAC listing' is its own checkbox.
A9272 is the opposite HCPCS, not a small E2402. A52511's payment-rule sentence is: Disposable wound suction pumps and related supplies (A9272) will be denied as statutorily noncovered because they do not meet the DME benefit. The coding guideline adds that disposable wound suction system pumps and related supplies must be coded A9272, that suction may be developed through any type of mechanism, that the code is all-inclusive, and that examples include SNaP, PICO, and VAC Via.1 Those examples are identity, not a printed −80 mm Hg statute. A disposable kit offered against an E2402 capital lot is a send-back even if someone writes 40–80 mm Hg on the bid. Architecture economics sit in single-use versus reusable NPWT pump.
View chart data
| Category | Lower bound (|mmHg|) | Upper bound (|mmHg|) |
|---|---|---|
| CMS A52511 E2402 window | 40 | 80 |
| Smith+Nephew RENASYS guideline | 40 | 125 |
| VEMERIX published envelope | 50 | 450 |
Values are unsigned magnitudes so envelopes can be compared on one axis. CMS prints 40-80 mm Hg sub-atmospheric pressure; the factory page prints a minus sign. A9272 is omitted because A52511 does not print a disposable mmHg band.
- CMS A52511 is a capability window, not an exclusive operating ceiling
- The VEMERIX published minimum is 50 mm Hg sub-atmospheric (−50 mmHg); it does not publish 40 mm Hg (−40 mmHg)
- The manufacturer guideline is labelled-use context, not the E2402 coding window
Source: CMS A52511 40-80 mm Hg capability window; Smith+Nephew RENASYS manufacturer guideline −40 to −125 mmHg; public VEMERIX pump page −50 to −450 mmHg.
How should a buyer read a −125 mm Hg IFU default or a manufacturer −40 to −125 mm Hg guideline without turning this page into a treatment protocol?
Clinic stocking notes treat modern NPWT pumps as commonly capable of settings up to −125 mmHg, with the actual pressure tailored to the wound rather than run at one fixed setting.8 Manufacturer guidelines for named systems can sit in a similar band: Smith+Nephew's RENASYS clinical guidelines recommend −40 to −125 mmHg.7 Neither figure is the A52511 40-80 mm Hg coding window.
Birke-Sorensen et al. 2011 (PMID 21868296) is the candidate expert-panel source for pressure-setting recommendations. The abstract records four pressure-setting recommendations and states that evidence for preferring any one NPWT treatment variable is relatively weak.6 This page does not reprint those four recommendations as a treatment protocol, and it does not treat Smith+Nephew's −40 to −125 mmHg band as the panel's printed range.
For a buyer, the rule is narrower: an IFU default or manufacturer guideline is labelled-use evidence that the hardware can deliver a clinician-chosen setting. It is not a tender eligibility statute and not a reason to overwrite A52511's 40-80 mm Hg capability window. Leave patient-specific pressure selection to the labelled IFU and the treating clinician.
When a factory quote prints −50 to −450 mmHg, what does that prove and what does it not prove?
The public VEMERIX Medical Vacuum NPWT Pump page records NMPA Class II registration Lu Mech Reg. 20182140303, continuously adjustable pressure −50 to −450 mmHg in 10 mmHg steps, continuous and intermittent modes, ±0.2% display error, suction flow 1.5–8.0 L/min, quiet operation under 45 dB, and gas-leak, overflow and overheat protections.5 CMS prints 40-80 mm Hg without a minus sign; the factory page prints a minus sign. Treat 40 mm Hg sub-atmospheric pressure and −40 mmHg as the same physical quantity written two ways.
What that published envelope does prove:
- A labelled manufacturer range and step: −50, −60, −70, −80 … −450 mmHg on the public page.
- Overlap with part of the CMS window: −50 to −80 mmHg overlaps 50–80 mm Hg of A52511's 40-80 mm Hg band.15
- Modes and some alarm names: continuous and intermittent operation, plus gas-leak, overflow and overheat protections as published. The public page does not list a line-occlusion alarm.
What it does not prove:
- Full 40-80 mm Hg capability: the published minimum is −50 mmHg. A52511's window includes 40 mm Hg sub-atmospheric pressure (−40 mmHg). A 10 mmHg step from −50 does not print that setting. Ask whether −40 is available; do not treat −50 as proof of the full coding window.
- A clinical default at −450 mmHg: the high end is published motor headroom. This page does not treat −450 mmHg as a labelled clinical setting.
- FDA 510(k), PDAC E2402, or CE: the public page does not publish those listings.5 OMP identity is not a substitute.3
- A CMS requirement to specify −450 mmHg: the 3 August VEMERIX tender guide FAQ still tells buyers to require −50 mmHg to at least −450 mmHg. That sentence is a spec preference on a sibling page, not A52511. This Daily run overlays it and does not silently edit that FAQ. See how to specify an NPWT system lot by lot.
Worked SKUs: VEMERIX NMPA Class II pump Lu Mech Reg. 20182140303 versus a disposable A9272 pump versus an E2402 pump with PDAC listing
Three labelled hypotheses, not three claimed 510(k) listings:
| Cell | SKU A: VEMERIX Medical Vacuum NPWT Pump | SKU B: Disposable wound suction (A9272 hypothesis) | SKU C: Labelled E2402 pump with PDAC listing |
|---|---|---|---|
| What is labelled | NMPA Class II, Lu Mech Reg. 20182140303; published −50 to −450 mmHg, 10 mmHg steps, continuous and intermittent | A52511 A9272: disposable wound suction, any mechanism, all-inclusive kit. Named examples include SNaP, PICO, VAC Via | A product with written PDAC Coding Verification Review published on the Product Classification List, billed E2402 |
| US device class / 510(k) | Not claimed on the public page. Do not assign this SKU to product code OMP as if a 510(k) existed | Do not assume QFC or OMP. Read the labelled 510(k) or CE file if the US or EU is in scope | OMP / 21 CFR 878.4780 is the usual powered-pump class, still not a 40-80 mm Hg statute |
| HCPCS / PDAC | No public PDAC E2402 listing. Do not tender as US Medicare E2402 | A9272; A52511 denies as statutorily noncovered DME. Send back if offered as E2402 | E2402 only after the PDAC list row exists. 40-80 wording is not that row |
| Alarms as published | Gas-leak, overflow, overheat. Line occlusion is not on the public page | Whatever the named disposable IFU prints; not A52511's E2402 sensor sentence | Must meet A52511's pressure-variation and canister-volume sensor sentence if billed E2402 |
| 40-80 mm Hg cell | Published envelope overlaps 50–80 mm Hg; does not publish 40 mm Hg (−40 mmHg). Ask before treating as full-window proof | Irrelevant to converting the kit into E2402 | Capability window inside the coding definition, not an exclusive max |
| Tender verdict | Usable published-range evidence for non-US hospital lots that accept NMPA identity. Not a US E2402 device in this article | Disposable lot only. Send back if offered against an E2402 capital cell | US DME lot only if the live PDAC list names that SKU |
Source: Public VEMERIX pump and dressing pages; CMS A52511 A9272 examples (SNaP, PICO, VAC Via); E2402+PDAC as a labelled US billing hypothesis, not a named SKU census.
SKU A is a published-range hypothesis, not a claimed E2402 device. The companion S.O.M.T dressing kit is not pressure-range proof and is not an A6550 billing credential.510 SKU C is unnamed on purpose: this page does not invent a PDAC Product Classification List extract.
The partner-supplied NOVACURE diode laser console (Guo Xie Zhu Zhun 20253011190, held by Guangdong Yunshang) is outside Medison's manufacturing scope and is not NPWT equipment.
Which files sit beside pressure range: OMP / 21 CFR 878.4780, ISO 10079-1 including AMD1:2026, IEC 60601-1-11, and why they are not the 40–80 coding window
Pressure range is one cell. These files sit beside it and are not the 40-80 mm Hg coding window:
- FDA product code OMP / 21 CFR 878.4780: OMP is Class II, 510(k). 21 CFR 878.4780 identifies a powered suction pump as a portable AC-powered or compressed-air-powered device; it does not print a 40-80 mm Hg band.34 Assigning VEMERIX to the OMP family as if a 510(k) existed is a send-back.
- ISO 10079-1 including AMD1:2026: As retrieved 21 September 2026, the OMP recognized-standards list includes ISO 10079-1 Fourth edition 2022-03 (FR Recognition Number 1-157) and ISO 10079-1:2022 including AMD1:2026 (FR Recognition Number 1-203; database identification 46933; Date of Entry 25 May 2026).312 FDA will accept declarations of conformity to Rec# 1-157 until 2 July 2028. This page does not parse the AMD1:2026 body for vacuum-category numbers and does not treat that standard as the CMS 40-80 window.
- IEC 60601-1-11 / GB 9706.1: Electrical-safety edition identity is a sibling file, not a pressure cell. See when a GB 9706.1 CoA is not IEC 60601-1 Edition 3.2.
Keep pneumatic performance evidence, electrical-safety CoAs, and HCPCS/PDAC authorization as separate packs. A suction-equipment standard does not rewrite A52511.
Distributor checklist: accept, ask-for-HCPCS-and-PDAC, or send-back-if-40-80-is-exclusive-max-or-if-minus-450-is-sold-as-Medicare
Hospital procurement leads, biomedical engineers, and international distributors should apply this decision framework when drafting or auditing an NPWT tender dossier as of 21 September 2026:
| Finding | What is at risk | What to request | Decision |
|---|---|---|---|
| RFQ copies 40–80 mm Hg as the only allowed operating range | Coding-capability window rewritten as a clinical ceiling | Clarify: pump must be controllable in 40-80 mm Hg; labelled IFU band is a separate cell | AMEND THE CELL |
| Bid claims E2402 from a 40–80 mm Hg brochure line | A52511 still requires a written PDAC Coding Verification Review on the Product Classification List | Ask for the live DMECS list row. Do not invent one | GATE ON PDAC |
| Disposable A9272 kit offered against an E2402 capital lot | A52511 denies A9272 as statutorily noncovered DME | Re-route to a disposable lot, or send back | SEND BACK |
| Factory quote prints −50 to −450 mmHg in 10 mmHg steps | Overlap with 50–80 mm Hg is not proof of 40 mm Hg (−40 mmHg) | Ask whether −40 is an available setting; keep HCPCS/PDAC/IFU as separate cells | ASK, THEN ACCEPT THE ENVELOPE AS PUBLISHED RANGE ONLY |
| −450 mmHg sold as a CMS or clinical requirement | Manufacturer maximum treated as Medicare or as a default setting | Strip the claim. The 3 August tender FAQ remains a spec preference, not A52511 | SEND BACK THE CLAIM |
| E2402 claimed without pressure-variation and canister-volume sensors | Missing A52511 sensor sentence for that coding definition | If the lot is not US E2402, do not import this gate. If it is, require the printed sensors | SEND BACK IF E2402 IS CLAIMED |
Source: Decision overlay on CMS A52511, LCD L33821, and the public VEMERIX pump page. Not a PDAC Product Classification List extract and not a clinical protocol.
Where VEMERIX fits—and where due diligence still begins
VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.5 In the perioperative care and wound therapy portfolio, Medison manufactures the NMPA-registered Class II Medical Vacuum NPWT Pump (Lu Mech Reg. 20182140303) and the companion Disposable NPWT Drainage Dressing Kit.510
The published pump envelope (−50 to −450 mmHg in 10 mmHg steps, continuous and intermittent, gas-leak, overflow and overheat protections, <45 dB, AC/DC plus spare battery) is the first positive signal for a non-US hospital lot that accepts NMPA identity.5 It overlaps 50–80 mm Hg of the CMS window and includes −125 mmHg as a reachable published setting. It does not publish 40 mm Hg (−40 mmHg), and it is not a 510(k), PDAC, or CE credential.
VEMERIX does not hold or claim an FDA 510(k) clearance, a PDAC E2402 listing, or a CE mark for this pump console.5 Due diligence still starts with the labelled HCPCS, PDAC status if E2402 is claimed, the IFU pressure band, and whether 40 mm Hg is an available setting. Request the current NMPA Class II certificate, ISO 13485 file, and electrical test reports for jurisdictions that accept that pack. Where US Medicare E2402 is required, specify a device that is actually on the PDAC list.
To review technical specifications, engineering test files, and companion dressing kit configurations, explore the VEMERIX Medical Vacuum NPWT Pump, inspect the S.O.M.T Disposable NPWT Drainage Dressing Kit, or contact the regulatory team via the Quality Assurance Portal, Document Download Center, or Commercial Enquiry Team.
Frequently Asked Questions
Q1: Does Medicare require an NPWT pump to operate only between 40 and 80 mm Hg?
No. A52511 says an E2402 pump is controllable to adjust the degree of sub-atmospheric pressure conveyed to the wound in a range of 40-80 mm Hg sub-atmospheric pressure.1 That is a capability window inside a coding definition, not an exclusive operating range.
Q2: Does a wider published range, such as −50 to −450 mmHg, automatically fail an E2402 spec?
No. A wider envelope does not by itself fail the capability reading. It also does not by itself prove the full 40-80 mm Hg window: a published minimum of −50 mmHg does not print 40 mm Hg (−40 mmHg).5 E2402 still needs PDAC listing and, if the US is in scope, a 510(k).12
Q3: Does a 40–80 mm Hg capability window replace PDAC Coding Verification Review?
No. A52511 allows E2402 billing only after a written PDAC Coding Verification Review is published on the appropriate Product Classification List.1 L33821 separately denies undesignated systems as not reasonable and necessary.2
Q4: Is −125 mm Hg the CMS coding range?
No. Clinic checklists and manufacturer guidelines often discuss settings up to −125 mmHg.78 That labelled-use band is not in A52511.
Q5: Is a disposable single-use NPWT pump billed as E2402?
No. Disposable wound suction is coded A9272 and is denied as statutorily noncovered DME under A52511.1 A52511 examples include SNaP, PICO and VAC Via; the article does not print a −80 mm Hg statute for those kits.
Q6: Does VEMERIX claim FDA 510(k) or PDAC E2402 listing for its NPWT pump in this article?
No. The public page records NMPA Class II Lu Mech Reg. 20182140303 and does not publish 510(k), PDAC E2402, or CE.5
Q7: Does FDA product code OMP set a 40–80 mm Hg pressure statute?
No. OMP and 21 CFR 878.4780 classify a powered suction pump as Class II 510(k) without printing the A52511 band.34
Q8: Should a tender require −450 mmHg because a factory publishes that maximum?
No. −450 mmHg is published manufacturer headroom, not a CMS requirement and not a claimed clinical default.5 The 3 August tender FAQ that asks for −50 to at least −450 mmHg remains a spec preference on a sibling page.