Identity
- Trade Name
- Fresh Whole Blood Donor Transfusion Set FDA UDI
- Generic Name
- Blood donor set, single-pack FDA UDI
- Device Name
- FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea FDA UDI
- Model / Reference
- 11 FDA UDI
- Description
- FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea FDA UDI
Identifiers
- Catalog Number
- 80-801-D FDA UDI
- Primary DI / UDI-DI
- M68980801D110 FDA UDI
- FDA Product Code
- PDQ FDA UDI
- GMDN Term
- Blood donor set, single-pack FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 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
Fresh Whole Blood Donor 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 |
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Manufacturer
- Manufacturer
- Safeguard Us Operating, Llc
Sources (1)
- FDA UDI 6ef66480-03b7-4192-b2e0-5d52401c9743 37 fields · synced May 30, 2026