HAWK Advanced Hypothermia Management Set 59-320

GUDID M68959320020

HAWK Advanced Hypothermia Management Set 1 ea - 23" x 20" HAWK Waring Grid w/ absorbent pad; 1 ea - 32" x 81" Thermal Patient Litter System Warning: Not for use on infants. Do not separate the HAWK Warming Grid from the absorbent pad. Device has the potential to produce burns. Always monitor and reassess during use.

Safeguard US Operating, LLC

Hypothermia-prevention whole-body suit

• Primary Device ID: M68959320020
• NIH Device Record Key: 9a2310c1-cac7-4fe0-99a1-0ee7b6775b3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAWK Advanced Hypothermia Management Set
• Version Model Number: 02
• Catalog Number: 59-320
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68959320020 [Primary]

FDA Product Code

• KME: Bedding, Disposable, Medical

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: 2022-09-07
• Device Publish Date: 2022-08-30

On-Brand Devices [HAWK Advanced Hypothermia Management Set]

• M68959320010: HAWK Advanced Hypothermia Management Set 1 ea - 23" x 20" HAWK Waring Grid with absorbent pad, 1
• M68959320020: HAWK Advanced Hypothermia Management Set 1 ea - 23" x 20" HAWK Waring Grid w/ absorbent pad; 1 e