HAWK Advanced Hypothermia Management Set 59-320

GUDID M68959320010

HAWK Advanced Hypothermia Management Set 1 ea - 23" x 20" HAWK Waring Grid with 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 IDM68959320010
NIH Device Record Key6d70e0d6-d90a-4a69-a646-5a4436b96867
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAWK Advanced Hypothermia Management Set
Version Model Number01
Catalog Number59-320
Company DUNS118492643
Company NameSafeguard US Operating, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM68959320010 [Primary]

FDA Product Code

KMEBedding, Disposable, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-04-12
Device Publish Date2018-03-28

On-Brand Devices [HAWK Advanced Hypothermia Management Set]

M68959320010HAWK Advanced Hypothermia Management Set 1 ea - 23" x 20" HAWK Waring Grid with absorbent pad, 1
M68959320020HAWK Advanced Hypothermia Management Set 1 ea - 23" x 20" HAWK Waring Grid w/ absorbent pad; 1 e

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.