AccessGUDID - DEVICE: Ice Compress 4"x7" (00850014433178)

GUDID

Device Identifier (DI) Information

Brand Name: Ice Compress 4"x7"
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DU1703
Company Name: DISTRIBUTION UNLIMITED, LLC

Primary DI Number: 00850014433178
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 926603486 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60790	Endothermic cold therapy pack	A device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns. It typically consists of a compact envelope made of plastic and filled with chemicals that generate an endothermic chemical reaction when activated to reduce the temperature of the pack. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMD	Pack, Hot Or Cold, Disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 7 Inch
Width: 4 Inch

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