Identity
- Trade Name
- Low Titer Type O FWB Transfusion Set FDA UDI
- Generic Name
- Blood transfusion set, non-exchange FDA UDI
- Device Name
- 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. Pre-screening to identify Type O Low Titer Donors in the operational forces is the next evolution in forward fresh whole blood resuscitation. This advancement simplifies this task by reducing the steps, supplies and time required to perform this lifesaving intervention. This self contained, low cube set is an affordable and sensible solution for training and equipping organizations that pre-identify their donors. FDA UDI
- Model / Reference
- 10 FDA UDI
- Description
- 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. Pre-screening to identify Type O Low Titer Donors in the operational forces is the next evolution in forward fresh whole blood resuscitation. This advancement simplifies this task by reducing the steps, supplies and time required to perform this lifesaving intervention. This self contained, low cube set is an affordable and sensible solution for training and equipping organizations that pre-identify their donors. FDA UDI
Identifiers
- Catalog Number
- 80-875 FDA UDI
- Primary DI / UDI-DI
- M68980875100 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 FWB 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 c72da963-f214-410e-aaea-8d889e437095 35 fields · synced May 30, 2026