Identity
- Trade Name
- Fresh Whole Blood Donor Transfusion Set FDA UDI
- Generic Name
- Blood donor set, single-pack FDA UDI
- Device Name
- The Fresh Whole Blood Donor Set contains everything needed to properly document donor information, screen for ABO/Rh, collect samples for retrospective testing and perform the collection of one unit of fresh whole blood in a compact sealed package. The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage. FDA UDI
- Model / Reference
- 14 FDA UDI
- Description
- The Fresh Whole Blood Donor Set contains everything needed to properly document donor information, screen for ABO/Rh, collect samples for retrospective testing and perform the collection of one unit of fresh whole blood in a compact sealed package. The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage. FDA UDI
Identifiers
- Catalog Number
- 80-801-D FDA UDI
- Primary DI / UDI-DI
- M68980801D140 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
- 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 donor set, single-pack
Fresh Whole Blood Donor Transfusion Set by Safeguard Us Operating, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 e86580f9-3530-41d5-9731-c03865e4d99a 37 fields · synced May 30, 2026