Valkyrie LTOWB Administration Set 80-821

GUDID M68980821110

This convenience kit is intended to be used by trained and credentialed individuals to treat blood loss or to supply blood due to an injury and secure a patent pathway for later medical needs. The Low Titer set is a special purpose transfusion kit intended for use only in organizations with an active pre-screening program that identifies its organic Low Titer Type O Negative donor pool.

Safeguard US Operating, LLC

Blood transfusion set, non-exchange

• Primary Device ID: M68980821110
• NIH Device Record Key: 5f99b257-ad28-44b1-8c24-366012f1b232
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valkyrie LTOWB Administration Set
• Version Model Number: 11
• Catalog Number: 80-821
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68980821110 [Primary]

FDA Product Code

• POQ: Blood Transfusion Kit

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: 2026-01-30
• Device Publish Date: 2026-01-22

On-Brand Devices [Valkyrie LTOWB Administration Set]

• M68980821050: VALKYRIE LTOWB ADMINISTRATION SET Constricting Band (18" x 1") 1 ea Gauze Sponge (4" x
• M68980821060: ADVANCED LTOWB ADMINISTRATION SET Constricting Band (18" x 1") 1 ea Gauze Sponge
• M68980821070: ADVANCED LTOWB ADMINISTRATION SET Constricting Band (18" x 1") 1 ea Gauze Sponge
• M68980821100: ADVANCED LTOWB ADMINISTRATION SET Constricting Band (18" x 1") 1 ea Gauze Sponge
• M68980821110: This convenience kit is intended to be used by trained and credentialed individuals to treat blo