AccessGUDID - DEVICE: Green Guard Instant Cold Pack (00347682033002)

GUDID

Device Identifier (DI) Information

Brand Name: Green Guard Instant Cold Pack
Version or Model: 3300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3300
Company Name: Greenguard

Primary DI Number: 00347682033002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176528040 *Terms of Use

Device Description: A device intended to be applied with pressure to the body surface to provide cold therapy - large

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
Special Storage Condition, Specify: Store at room temperature. Storage at cooler temperatures could cause frostbite after activation

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 35cb9b89-397e-4cf8-9c34-6abd9aa4f2cc
Public Version Date: July 04, 2019
Public Version Number: 1
DI Record Publish Date: June 26, 2019