Identity
- Trade Name
- OnGaurd2 CSTD Catheter Adaptor FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- The product is part of OnGuard2 Chemfort system for use with Chemfort / OnGuard2 CSTD Syringe Adaptor / Syringe Adaptor Lock The distal end of the Catheter Adaptor connect to a urinary catheter The proximal end of e Catheter Adaptor connects to Syringe Adaptor / Syringe Adaptor Lock FDA UDI
- Model / Reference
- 412182 FDA UDI
- Description
- The product is part of OnGuard2 Chemfort system for use with Chemfort / OnGuard2 CSTD Syringe Adaptor / Syringe Adaptor Lock The distal end of the Catheter Adaptor connect to a urinary catheter The proximal end of e Catheter Adaptor connects to Syringe Adaptor / Syringe Adaptor Lock FDA UDI
Identifiers
- Primary DI / UDI-DI
- 27290115921827 FDA UDI
- 510(k) Number
- K231286 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
OnGaurd2 CSTD Catheter Adaptor by Simplivia Healthcare Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
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 d4434b4b-1f67-4725-9c49-e13e615225c6 34 fields · synced May 30, 2026