FDA UDI In Commercial Distribution 🇺🇸 United States

Basic

DI: B845ICE106900 · Model: ICE1069 · Intco Medical Industries, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
Basic
Primary DI
B845ICE106900
Version / Model
ICE1069
Company Name
Intco Medical Industries, Inc.
Labeler DUNS
080162537
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-28
Public Version
1
Public Version Date
2023-05-08
Public Version Status
New
Public Device Record Key
fd20481f-d1e5-4c80-9226-24c9a7c6044b

Device Description

INSTANT COLD PACK

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
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
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
Primary B845ICE106900
Package B845ICE106933