Fresh Whole Blood Recipient Set 80-801-R

GUDID M68980801R080

FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge 2 ea Safety IV Catheter 16gx1.25" 1 ea Safety IV Catheter 18gx1.25" 1 ea IV Set "Y" - Type with Filter 1 ea Surgical Tape 1 ea Clear IV Dressing 1 ea ABO/Rh Screen (EldonCard) 1 ea Gloves 1 pr Alcohol Pads 2 ea Chlorhexidine Swab 1 ea Permanent Marker 1 ea SF 518 1 ea Instructions for Use 1 ea

Safeguard US Operating, LLC

Blood transfusion set, non-exchange

• Primary Device ID: M68980801R080
• NIH Device Record Key: b4846301-3cc0-4c6a-b172-68d070971b43
• Commercial Distribution Discontinuation: 2023-06-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Fresh Whole Blood Recipient Set
• Version Model Number: 08
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68980801R080 [Primary]

FDA Product Code

• BRZ: Set, Blood Transfusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-12-17
• Device Publish Date: 2022-09-30

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