UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233965 FDA 510(k)
- FDA Product Code
- ITX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1570 FDA 510(k)
- Regulation Number
- 892.1570 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The UltraDrape UGPIV Barrier and Securement (34-15) is a sterile, single-use peripheral intravenous (UGPIV) securement device designed to protect insertion sites from contamination and dislodgement. It features a barrier drape to maintain aseptic conditions while securing the catheter in place, reducing the risk of infection and improving patient comfort during intravenous therapy.
This device is supplied sterile in a sealed package and intended for use in clinical settings such as hospitals and outpatient care facilities. It is classified under the product code ITX and is intended for single-use only, ensuring patient safety and compliance with infection control protocols. The UltraDrape UGPIV Barrier and Securement (34-15) has received FDA 510(k) clearance and conforms to the Medical Device Directive (MDD)
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K233965 | Class II | Active |
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Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
Sources (2)
- FDA 510(k) K233965 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026