Ice Compress 4"x7" - Instant Ice Compress is a device that consists of - DISTRIBUTION UNLIMITED, LLC

Duns Number:926603486

Device Description: Instant Ice Compress is a device that consists of two bags; one containing water, inside a 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.

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More Product Details

Catalog Number

DU1703

Brand Name

Ice Compress 4"x7"

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IMD

Product Code Name

Pack, Hot Or Cold, Disposable

Device Record Status

Public Device Record Key

4c8645f5-a8e3-4342-ab02-c2c0afb75730

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Additional Identifiers

Package DI Number

10850014433175

Quantity per Package

50

Contains DI Package

00850014433178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"DISTRIBUTION UNLIMITED, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 1