Identity
- Trade Name
- Low Titer Type O Donor Collection Set FDA UDI
- Generic Name
- Blood transfusion set, non-exchange FDA UDI
- Device Name
- LOW TITER TYPE O DONOR COLLECTION SET Constricting Band (18"x1") 1 ea Safety IV Catheter 16gx1.25" 2 ea Transparent Film Dressing 2 ea Chlorhexidine Swap 4 ea Blood Collection Bag 1 ea Beaded Cable Tie 1ea Needle-Free Valve with Luer Lock 2 ea DD Form 572 1 ea FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- LOW TITER TYPE O DONOR COLLECTION SET Constricting Band (18"x1") 1 ea Safety IV Catheter 16gx1.25" 2 ea Transparent Film Dressing 2 ea Chlorhexidine Swap 4 ea Blood Collection Bag 1 ea Beaded Cable Tie 1ea Needle-Free Valve with Luer Lock 2 ea DD Form 572 1 ea FDA UDI
Identifiers
- Catalog Number
- 80-875-D FDA UDI
- Primary DI / UDI-DI
- M68980875D010 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 Donor Collection 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 |
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Manufacturer
- Manufacturer
- Safeguard Us Operating, Llc
Sources (1)
- FDA UDI 8b270e0a-2191-4ca6-bd90-4279b5043aaf 36 fields · synced May 30, 2026