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HAWK Advanced Hypothermia Management Set

FDA UDI

Class I (US FDA UDI)

by Safeguard Us Operating, Llc

Identity

Trade Name
HAWK Advanced Hypothermia Management Set FDA UDI
Generic Name
Hypothermia-prevention whole-body suit FDA UDI
Device Name
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. FDA UDI
Model / Reference
01 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
59-320 FDA UDI
Primary DI / UDI-DI
M68959320010 FDA UDI
FDA Product Code
KME FDA UDI
IMD FDA UDI
GMDN Term
Hypothermia-prevention whole-body suit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6060 FDA UDI
890.5710 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

HAWK Advanced Hypothermia Management Set by Safeguard Us Operating, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Safeguard Us Operating, Llc

Sources (1)

  • FDA UDI 6d70e0d6-d90a-4a69-a646-5a4436b96867 35 fields · synced May 31, 2026