Fresh Whole Blood Donor Transfusion Set

FDA UDI

by Safeguard Us Operating, Llc

Identity

Trade Name: Fresh Whole Blood Donor Transfusion Set FDA UDI
Generic Name: Blood donor set, single-pack FDA UDI
Device Name: Designed for missions in the most remote and austere environments, the Fresh Whole Blood Donor Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. 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 Donor Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood Donor in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. Combat Capabilities • Easily administered • Simplifies training • Compact lightweight • Cost effective Product Attributes • 100% TAA compliant components (no waivers required) DONOR SET- PN: 80-801-D is: • Assembled in GMP facility. • Adhesive blood bag label for recording donor information. • EldonCard™: ABO/Rh blood-typing card for simple, accurate, and fast results. • Re-sealable bag used to send all supplies back with casualty for retrospective testing. DONOR SET- PN: 80-801-D • Constricting Band (18”x1”) 1 ea Gloves (Pair) 1 ea • Gauze Sponge (4”x4”) 2 ea Alcohol Pads 2 ea • Blood Tube- Pearl Top 3 ea Chloraprep Swabstick 1 ea • Blood Tube- Gold Top 2 ea 5.5” Kelly Clamp 1 ea • Blood Tube- Lavender Top 1 ea Nylon Cord (10”) 1 ea • Blood Collection Needle 1 ea FDA UDI
Model / Reference: 2 FDA UDI
Description: Designed for missions in the most remote and austere environments, the Fresh Whole Blood Donor Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. 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 Donor Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood Donor in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. Combat Capabilities • Easily administered • Simplifies training • Compact lightweight • Cost effective Product Attributes • 100% TAA compliant components (no waivers required) DONOR SET- PN: 80-801-D is: • Assembled in GMP facility. • Adhesive blood bag label for recording donor information. • EldonCard™: ABO/Rh blood-typing card for simple, accurate, and fast results. • Re-sealable bag used to send all supplies back with casualty for retrospective testing. DONOR SET- PN: 80-801-D • Constricting Band (18”x1”) 1 ea Gloves (Pair) 1 ea • Gauze Sponge (4”x4”) 2 ea Alcohol Pads 2 ea • Blood Tube- Pearl Top 3 ea Chloraprep Swabstick 1 ea • Blood Tube- Gold Top 2 ea 5.5” Kelly Clamp 1 ea • Blood Tube- Lavender Top 1 ea Nylon Cord (10”) 1 ea • Blood Collection Needle 1 ea FDA UDI

Identifiers

Catalog Number: 80-801-D FDA UDI
Primary DI / UDI-DI: M68980801D020 FDA UDI
GMDN Term: Blood donor set, single-pack FDA UDI

Classification

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 Donor Transfusion Set by Safeguard Us Operating, Llc — 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	N/A	Pending data

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Manufacturer

Manufacturer: Safeguard Us Operating, Llc

Sources (1)

FDA UDI bb04ea96-595a-4cd1-8b31-0bdfcc151b80 37 fields · synced May 30, 2026