Fresh Whole Blood Donor Transfusion Set 80-801-D

GUDID M68980801D150

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.

Safeguard US Operating, LLC

Blood donor set, single-pack

• Primary Device ID: M68980801D150
• NIH Device Record Key: c0bf3e25-fea5-4408-ab96-015cdc019d91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fresh Whole Blood Donor Transfusion Set
• Version Model Number: 15
• Catalog Number: 80-801-D
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 20 to 25 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68980801D150 [Primary]

FDA Product Code

• PDQ: Neurosurgical Nerve Locator

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 Donor Transfusion Set]

• M68980801D0: Designed for missions in the most remote and austere environments, the Fresh Whole Blood Donor S
• M68980801D110: FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea
• M68980801D140: The Fresh Whole Blood Donor Set contains everything needed to properly document donor informatio
• M68980801D150: The Fresh Whole Blood Donor Set contains everything needed to properly document donor informatio