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 1 ea Safety IV Catheter 16g x 1.25" 2 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 FDA UDI
- Model / Reference
- 03 FDA UDI
- Description
- LOW TITER TYPE O DONOR COLLECTION SET Constricting Band 1 ea Safety IV Catheter 16g x 1.25" 2 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 FDA UDI
Identifiers
- Catalog Number
- 80-875-D FDA UDI
- Primary DI / UDI-DI
- M68980875D030 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
- 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
Category: Blood transfusion set, non-exchange
Low Titer Type O Donor Collection Set by Safeguard Us Operating, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood transfusion set, non-exchange.
- Blood Administration Set — Merit Pharmaceutical · Class II
- Walrus — CODAN US Corporation · Class II
- Walrus — CODAN US Corporation · Class II
- Blood Administration Set — B. BRAUN MEDICAL INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- CLEARLINK — BAXTER INTERNATIONAL INC. · Class II
- CODAN — CODAN US Corporation · Class II
- Walrus — CODAN US Corporation · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Safeguard Us Operating, Llc
Sources (1)
- FDA UDI adeff5a0-971c-4086-afdd-a163506cc3cb 35 fields · synced May 31, 2026