Fresh Whole Blood Recipient Set 80-801-R

GUDID M68980801R110

he Fresh Whole Blood Recipient Set contains everything needed to properly document recipient information, screen for ABO/Rh compatibility and transfuse 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.

Safeguard US Operating, LLC

Blood transfusion set, non-exchange

• Primary Device ID: M68980801R110
• NIH Device Record Key: dcbe0cfd-2413-45a7-a2b8-d5d5761fa11b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fresh Whole Blood Recipient Set
• Version Model Number: 11
• Catalog Number: 80-801-R
• Company DUNS: 118492643
• Company Name: Safeguard US Operating, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68980801R110 [Primary]

FDA Product Code

• BRZ: Set, Blood Transfusion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-12
• Device Publish Date: 2025-03-04

On-Brand Devices [Fresh Whole Blood Recipient Set]

• M68980801R020: Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfu
• M68980801R01: Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfu
• M68980801R070: FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge
• M68980801R080: FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge
• M68980801R110: he Fresh Whole Blood Recipient Set contains everything needed to properly document recipient inf