Identity
- Trade Name
- OnGuard2 20mm Vial Adaptor, 5 Units FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- OnGuard2 Vial Adaptor, 5 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to 20mm neck drug vial The device proximal end is intended to connect to OnGuard2 Syringe Adaptor (or Syringe Adaptor Lock) FDA UDI
- Model / Reference
- 412187 FDA UDI
- Description
- OnGuard2 Vial Adaptor, 5 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to 20mm neck drug vial The device proximal end is intended to connect to OnGuard2 Syringe Adaptor (or Syringe Adaptor Lock) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 27290115921872 FDA UDI
- 510(k) Number
- K192866 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
OnGuard2 20mm Vial Adaptor, 5 Units by Simplivia Healthcare Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medication transfer set.
- Equashield — Equashield Medical Ltd. · 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
- 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
K192866 also covers:
- ONGUARD2 20mm VIAL ADAPTOR SL with 13 mm convertor — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 20mm Vial Adaptor, 10 Units — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 Bag Adaptor SP II — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 Syringe Adaptor Lock II — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 Syringe Adaptor Lock II, 5 Units — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 Syringe Adaptor Sterile Replacement Cap — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 Syringe Adaptor, 5 Units — SIMPLIVIA HEALTHCARE LTD
- OnGuard®2 20mm Vial Adaptor II and 13mm convertor — SIMPLIVIA HEALTHCARE LTD
- OnGuard®2 CSTD 20mm Vial Adaptor and 13mm Convertor — SIMPLIVIA HEALTHCARE LTD
- OnGuard®2 CSTD 28mm Vial Adaptor — SIMPLIVIA HEALTHCARE LTD
- OnGuard®2 CSTD Bag Adaptor SP — SIMPLIVIA HEALTHCARE LTD
- OnGuard®2 CSTD Luer Lock Adaptor — SIMPLIVIA HEALTHCARE LTD
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Simplivia Healthcare Ltd
Sources (1)
- FDA UDI 68e37d34-7436-4a09-acc3-9343677c834d 35 fields · synced Jun 8, 2026