18Surgical · Post-op
Disposable Catheter Fixer (Set)
Single-use catheter securement set for post-procedure stability.
Classification
Class I
A single-use catheter fixer set that secures indwelling catheters and lines after surgical placement. Listed on VEMERIX's official catalogue alongside the circumcision and post-op protection range.
KEY FEATURES
What makes it work.
- Single-use, sterile-packaged
- Hypoallergenic adhesive base
- Rapid application during nursing handover
- Compatible with common indwelling catheter sizes
APPLICATIONS
Where it's used.
- Post-procedure catheter and line securement
SPECIFICATIONS
Technical specifications.
Classification
Class I medical device
Form
Single-use sterile set
FROM VEMERIX INSIGHTS
Market analysis behind this product
Buyer Guide
What the FDA MAUDE and Recall Record Reveals About Catheter and Tube Securement Device Failures: A Post-Market Evidence Map for Securement Procurement and Supplier Screening (2015–2026)
An original FDA post-market surveillance analysis of 1,125 MAUDE medical device reports, a 20-action recall record, and the 510(k)-exempt Class I regulatory baseline (21 CFR 880.5210, product codes KMK, CBH, OKC) translated into tender specifications, acceptance testing, and supplier-screening criteria for vascular-access and catheter-fixation procurement.
August 14, 2026 · 16 min read
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
Buyer Guide
Catheter Securement Device Selection and Sourcing: An Adhesive, Integrated, Subcutaneous-Anchor and Tissue-Adhesive Buyer's Guide with US, EU and China Classification
A cross-jurisdiction buyer guide for medical device distributors, OEM buyers, and procurement teams evaluating catheter securement designs, regulatory classes, openFDA recall failure modes, and supplier qualification standards.
August 3, 2026 · 16 min read
Technical Guide
Ethylene Oxide Sterilization Validation for Single-Use Medical Devices: An ISO 11135 Process, ISO 10993-7 Residual and FDA Evidence Guide for OEM and Private-Label Buyers
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
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Sample units typically ship under 10 business days for qualified buyers. Distributors — ask about territory exclusivity.