Identity
- Trade Name
- Low Titer Type O FWB Transfusion Set FDA UDI
- Generic Name
- Blood transfusion set, non-exchange FDA UDI
- Device Name
- LOW TITER TYPE O FWB TRANSFUSION SET Constricting Band 1 ea Safety IV Catheter 16g x 1.25" 2 ea IV Set "Y" - Type with Filter 1 ea Transparent Film Dressing 2 ea Chlorhexidine Swab 4 ea Blood Collection Bag 1 ea Blood Bag Label 1 ea Beaded Cable Tie 1 ea Needle Port 2 ea ASBP 572 1 ea SF 518 1 ea FDA UDI
- Model / Reference
- 07 FDA UDI
- Description
- LOW TITER TYPE O FWB TRANSFUSION SET Constricting Band 1 ea Safety IV Catheter 16g x 1.25" 2 ea IV Set "Y" - Type with Filter 1 ea Transparent Film Dressing 2 ea Chlorhexidine Swab 4 ea Blood Collection Bag 1 ea Blood Bag Label 1 ea Beaded Cable Tie 1 ea Needle Port 2 ea ASBP 572 1 ea SF 518 1 ea FDA UDI
Identifiers
- Catalog Number
- 80-875 FDA UDI
- Primary DI / UDI-DI
- M68980875070 FDA UDI
- FDA Product Code
- BRZ FDA UDI
- GMDN Term
- Blood transfusion set, non-exchange 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
No
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Low Titer Type O FWB Transfusion Set by Safeguard Us Operating, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Safeguard Us Operating, Llc
Sources (1)
- FDA UDI bdbe2294-7e98-41bf-b145-93d370fed9b5 36 fields · synced May 30, 2026