Identity
- Trade Name
- OnGuard Spike Port Adaptor FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- The Spike Port Adaptor is part of the OnGuard CSTD system. The devices spike connects to IV solution container. The proximal end connects to IV set spike, to allow administration. The port connects to OnGuard2 Syringe Adaptor to transfer drug or withdraw saline / drug. FDA UDI
- Model / Reference
- 412113 FDA UDI
- Description
- The Spike Port Adaptor is part of the OnGuard CSTD system. The devices spike connects to IV solution container. The proximal end connects to IV set spike, to allow administration. The port connects to OnGuard2 Syringe Adaptor to transfer drug or withdraw saline / drug. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 37290115921138 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
- 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
Category: Medication transfer set
OnGuard Spike Port Adaptor by Simplivia Healthcare Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medication transfer set.
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- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
Cleared under the same submission
K141448 also covers:
- 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 fe6ea7b9-523b-408a-a3eb-5f679893fb1b 35 fields · synced Jun 1, 2026