09NPWT · Disposables
Disposable NPWT Drainage Dressing Kit
Side-suction multi-chamber NPWT dressing kit (S.O.M.T technology).
Classification
Class II
A purpose-built dressing kit pairing VEMERIX’s side-suction multi-chamber drainage cup (S.O.M.T NPWT) with PVA / PU foam, biological semi-permeable membrane and tee connector. Engineered to maximize drainage while minimizing tube blockage and false alarms.
KEY FEATURES
What makes it work.
- Proprietary S.O.M.T side-suction multi-chamber cup
- Independent drainage and injection lines
- PVA / PU sponge in multiple shapes and sizes
- Biological semi-permeable membrane: breathable, moisturizing, bacteria-blocking
- 400–600 µm pore structure for even pressure distribution
- Tee connector + extension tube included
APPLICATIONS
Where it's used.
- Acute wounds
- Chronic and traumatic wounds
- Subacute and split wounds
- Second-degree burn wounds
- Venous ulcers and diabetic ulcers
- Skin grafts and flaps
CONTRAINDICATIONS
- Unclean wounds / wounds with necrotic eschar
- Wounds with tumor tissue
- Sinus tracts connected to organs
- Wounds with large blood vessels or exposed organs
SPECIFICATIONS
Technical specifications.
Classification
Class II medical device
Variants
Type I-PVA · Type II-PVA · Type I-PU · Type II-PU
Pore structure
400 – 600 µm
Patents
ZL 201210207084.7 (invention); ZL 201220294512X (utility)
Patents
ZL 201210207084.7 (invention)
ZL 201220294512X (utility)
FROM VEMERIX INSIGHTS
Market analysis behind this product
Technical Guide
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A practical buyer's audit guide for medical device biological safety files: matching endpoints to contact category and duration, verifying test-article final form, navigating the ISO 10993-1:2025 transition across FDA, EU MDR and China NMPA, and spotting disqualifying file gaps.
August 22, 2026 · 18 min read
Evidence Review
Wound Debridement Before the Vacuum: What Medicare Data Shows About Where NPWT Actually Sits in Care (2026)
Medicare professional-service data and current wound guidance show why debridement and dressings define the pathway—and why NPWT remains a selective downstream adjunct.
August 17, 2026 · 28 min read
Regulatory Guide
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A definitive regulatory pathway, post-market recall analysis, and supplier-qualification checklist for multi-component sterile procedure trays, circumcision kits, puncture sets, and dressing packs.
August 15, 2026 · 18 min read
Buyer Guide
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The FDA itself splits NPWT into reusable powered, non-powered mechanical and disposable powered single-use pumps under three different Class II product codes, and the right buy flows from exudate volume, wound complexity, care setting and reimbursement path rather than a blanket claim that disposable is better.
August 8, 2026 · 16 min read
Buyer Guide
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August 6, 2026 · 15 min read
Evidence Review
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Buyer Guide
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Technical Guide
Radiation (Gamma, Electron-Beam and X-Ray) Sterilization Validation for Single-Use Medical Devices: An ISO 11137, VDmax and FDA Evidence Guide for OEM and Private-Label Buyers
Qualifying a radiation-sterilized single-use device OEM requires verifying an ISO 11137 validation protocol, substantiating the 25 kGy or 15 kGy sterilization dose via VDmax, selecting the optimal modality (gamma vs e-beam vs X-ray), capping polymer maximum doses, and aligning with the 4-month dose-audit interval under ISO 11137-1:2025 and the FDA Radiation Master File Pilot.
August 4, 2026 · 18 min read
Technical Guide
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Qualifying a sterile single-use device OEM demands a validated ISO 11135 process, documented ISO 10993-7 residual dissipation profiles below 4 mg EO / 9 mg ECH for limited contact, clear parametric or BI release protocols, and a regulatory change-control strategy under the FDA Sterilization Master File pilots.
August 3, 2026 · 16 min read
Buyer Guide
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An ISO 13485 certificate is the opening question—not the answer.
August 3, 2026 · 24 min read
Evidence Review
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Navigating NPWT dressing selection requires separating material mechanics from clinical healing claims—evaluating open-pore PU black foam (400–600 µm) for high-exudate granulation against hydro-retentive PVA white foam for sensitive wound beds, respecting the 48–72 hour open-wound change boundary, and understanding the FDA regulatory divide between open-wound (OMP) and closed-incision (QFC) devices.
August 3, 2026 · 15 min read
Buyer Guide
How to Specify a Negative Pressure Wound Therapy (NPWT) System: A Lot-by-Lot Tender, RFQ & Acceptance Checklist for Pumps, Dressings and Canisters (2026)
A hospital procurement, health-system category management, or distributor team specifying negative pressure wound therapy (NPWT) should not issue a single bundled RFQ. Structure tenders into platform lots (acute heavy-duty, portable ambulatory, single-use/disposable, consumables, rental), map every pump performance and alarm requirement directly to documented FDA failure modes (leak, occlusion, canister overflow, power thermal cutoff), and demand a 6-part regulatory evidence pack (510(k), UDI, ISO 10993, IEC 60601-1, EO sterilization) before awarding volume.
August 3, 2026 · 18 min read
Technical Guide
Sterile Barrier Packaging and Shelf-Life Validation for Single-Use Medical Devices: An ISO 11607 and Accelerated-Aging Acceptance Guide
Passing ISO 11607 requires more than a cleanroom pouch—it demands a validated forming and sealing process under Part 2, Arrhenius accelerated-aging calculations under ASTM F1980 confirmed by real-time stability, transport simulation under ASTM D4169, and lot-release seal strength and integrity criteria.
August 3, 2026 · 16 min read
Regulatory Guide
Unique Device Identification (UDI) for Private-Label and OEM Single-Use Medical Devices: A US (FDA), EU (MDR/EUDAMED) and China (NMPA) Decision Matrix
Determining who holds the UDI-DI, which issuing agency to use, and when database submission becomes mandatory under 21 CFR 830, EU MDR Article 27, and NMPA UDI Rules.
August 3, 2026 · 22 min read
Market Analysis
From the Pump Cart to the Pocket: The Disposable Shift in Negative-Pressure Wound Therapy
How wound care is repeating the move from a durable capital device to a registered single-use consumable — and why the recurring disposable kit, not the pump, is the strategic prize for device makers and distributors.
July 1, 2026 · 31 min read
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