FDA UDI
In Commercial Distribution
🇺🇸 United States
Medi-First Cold Compress Large
DI: 00347682702014
·
Model: 70201
·
Medique Products
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Medi-First Cold Compress Large
- Primary DI
- 00347682702014
- Version / Model
- 70201
- Catalog Number
- 70201
- Company Name
- Medique Products
- Labeler DUNS
- 086911794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-12
- Public Version
- 1
- Public Version Date
- 2019-07-22
- Public Version Status
- New
- Public Device Record Key
- 68b7d4e2-c5a4-446a-9f04-3c61b783eb43
Device Description
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.
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 | 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 |
|---|---|---|---|---|---|---|
| Package | 50347682702019 | GS1 | master case | 24 | In Commercial Distribution | |
| Primary | 00347682702014 | GS1 |
Customer Contacts
- Phone
- 1-800-634-7680
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature. Storage at cooler temperatures could cause frostbite after activation