FDA UDI In Commercial Distribution 🇺🇸 United States

Green GuardInstant Cold Pack

DI: 00347682033026 · Model: 3302 · Greenguard
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Green GuardInstant Cold Pack
Primary DI
00347682033026
Version / Model
3302
Catalog Number
3302
Company Name
Greenguard
Labeler DUNS
176528040
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-06-26
Public Version
1
Public Version Date
2019-07-04
Public Version Status
New
Public Device Record Key
2876a2e3-c745-4c11-aa86-1fb55ea352dd

Device Description

A device intended to be applied with pressure to the body surface to provide cold therapy - Medium

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IMD Pack, Hot Or Cold, Disposable

GMDN Terms

Code Name
60790 Endothermic cold therapy pack

Identifiers

Type ID
Package 50347682033021
Primary 00347682033026

Customer Contacts

Storage Conditions

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