Fresh Whole Blood Recipient Set

FDA UDI

Class II (US FDA UDI)

by Safeguard Us Operating, Llc

Identity

Trade Name: Fresh Whole Blood Recipient Set FDA UDI
Generic Name: Blood transfusion set, non-exchange FDA UDI
Device Name: Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfusion Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. The set includes a donor module, blood collection bag and recipient module; that allow for donor collection and the ability to perform a transfusion procedure to the recipient. Product Description In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. RECIPIENT SET -PN: 80-801-R • Constricting Band (18”x1”) 1 ea • Gauze Sponge (4”x4”) 2 ea • Safety IV Catheter 16g x 1.25” 1 ea • Safety IV Catheter 18g x 1.25” 1 ea • IV Set “Y”-Type with filter 1 ea • Surgical Tape 1 ea • Clear IV Dressing 1 ea • ABO/Rh Screen (Eldon Card) 1 ea • Gloves (Pair) 1 ea • Alcohol Pads 2 ea • Chloraprep Swabstick 1 ea • Mini-Sharpie 1 ea • SF 518Form 1 ea • Instructions for Use 1 ea FDA UDI
Model / Reference: 1 FDA UDI
Description: Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfusion Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. The set includes a donor module, blood collection bag and recipient module; that allow for donor collection and the ability to perform a transfusion procedure to the recipient. Product Description In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. RECIPIENT SET -PN: 80-801-R • Constricting Band (18”x1”) 1 ea • Gauze Sponge (4”x4”) 2 ea • Safety IV Catheter 16g x 1.25” 1 ea • Safety IV Catheter 18g x 1.25” 1 ea • IV Set “Y”-Type with filter 1 ea • Surgical Tape 1 ea • Clear IV Dressing 1 ea • ABO/Rh Screen (Eldon Card) 1 ea • Gloves (Pair) 1 ea • Alcohol Pads 2 ea • Chloraprep Swabstick 1 ea • Mini-Sharpie 1 ea • SF 518Form 1 ea • Instructions for Use 1 ea FDA UDI

Identifiers

Catalog Number: 80-801-R FDA UDI
Primary DI / UDI-DI: M68980801R01 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Fresh Whole Blood Recipient 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 eb240981-d15d-45fe-aebc-afce2a995da7 36 fields · synced May 30, 2026