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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | 890.5710 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B845ICE106900 | HIBCC | ||||
| Package | B845ICE106933 | HIBCC | 50 | In Commercial Distribution |