Ice Compress 4"x7"

FDA UDI

Class I (US FDA UDI)

by Distribution Unlimited, Llc

Identity

Trade Name: Ice Compress 4"x7" FDA UDI
Generic Name: Endothermic cold therapy pack FDA UDI
Device Name: Instant Ice Compress is a device that consists of two bags; one containing water, inside a bag containing ammonium nitrate, calcium ammonium nitrate or urea. When the inner bag of water is broken by squeezing the package, it dissolves the solid in an endothermic reaction. FDA UDI
Model / Reference: 1 FDA UDI
Description: Instant Ice Compress is a device that consists of two bags; one containing water, inside a bag containing ammonium nitrate, calcium ammonium nitrate or urea. When the inner bag of water is broken by squeezing the package, it dissolves the solid in an endothermic reaction. FDA UDI

Identifiers

Catalog Number: DU1703 FDA UDI
Primary DI / UDI-DI: 00850014433178 FDA UDI
FDA Product Code: IMD FDA UDI
GMDN Term: Endothermic cold therapy pack FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5710 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 7 Inch FDA UDI
Width — 4 Inch FDA UDI

Category: Endothermic cold therapy pack

Ice Compress 4"x7" by Distribution Unlimited, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Distribution Unlimited, Llc

Sources (1)

FDA UDI 4c8645f5-a8e3-4342-ab02-c2c0afb75730 35 fields · synced May 30, 2026