Identity
- Trade Name
- OnGuard Luer Lock Adaptor FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- The Luer Lock Adaptor is part of the OnGuard CSTD system. The proximal end connects to female luer lock of the IV set. The OnGuard2 Syringe Adaptor / Lock connects to the Lusr Lock Adaptor port FDA UDI
- Model / Reference
- 412114 FDA UDI
- Description
- The Luer Lock Adaptor is part of the OnGuard CSTD system. The proximal end connects to female luer lock of the IV set. The OnGuard2 Syringe Adaptor / Lock connects to the Lusr Lock Adaptor port FDA UDI
Identifiers
- Primary DI / UDI-DI
- 27290115921148 FDA UDI
- 510(k) Number
- K141448 FDA UDI
- FDA Product Code
- ONB FDA UDI
- GMDN Term
- Medication transfer set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
OnGuard Luer Lock Adaptor by Simplivia Healthcare Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K141448 also covers:
- OnGuard Spike Port Adaptor — SIMPLIVIA HEALTHCARE LTD
- TEVADAPTOR® 28mm Vial Adaptor — TEVA PHARMACEUTICAL INDUSTRIES LIMITED
- TEVADAPTOR® Connecting Set — TEVA PHARMACEUTICAL INDUSTRIES LIMITED
- TEVADAPTOR® Luer Lock Adaptor — TEVA PHARMACEUTICAL INDUSTRIES LIMITED
- TEVADAPTOR® Spike Port Adaptor — TEVA PHARMACEUTICAL INDUSTRIES LIMITED
- TEVADAPTOR® Syringe Adaptor — TEVA PHARMACEUTICAL INDUSTRIES LIMITED
- TEVADAPTOR® Vial Adaptor — TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Simplivia Healthcare Ltd
Sources (1)
- FDA UDI 4a3cb721-00fc-4adb-83da-a1eb91e362b1 36 fields · synced May 30, 2026