Fresh Whole Blood Transfusion Set 80-801

GUDID M689808010

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. Combat Capabilities • Easily administered • Simplifies training • Compact lightweight • Cost effective Product Attributes • 100% TAA compliant components (no waivers required) • Donor and recipient specific modules • Shelf life: 12 months • Made in USA Clinical Benefit • Assembled in FDA registered 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.

Safeguard US Operating, LLC

Blood transfusion set, non-exchange

• Primary Device ID: M689808010
• NIH Device Record Key: 640b1359-dfff-4eb5-bdf2-32a8b4ba8fe3
• Commercial Distribution Discontinuation: 2021-10-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Fresh Whole Blood Transfusion Set
• Version Model Number: 2
• Catalog Number: 80-801
• 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
• 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
• 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	M689808010 [Previous]
HIBCC	M68980801020 [Primary]

FDA Product Code

• POQ: Blood Transfusion Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-04-12
• Device Publish Date: 2017-08-04

On-Brand Devices [Fresh Whole Blood Transfusion Set]

• M689808010: Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfu
• M68980801050: FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-80
• M68980801040: FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-80