FDA UDI
In Commercial Distribution
🇺🇸 United States
Cramer Instant Cold Pack
DI: 00311960410304
·
Model: 033101
·
CRAMER PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Cramer Instant Cold Pack
- Primary DI
- 00311960410304
- Version / Model
- 033101
- Company Name
- CRAMER PRODUCTS, INC.
- Labeler DUNS
- 007138183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-19
- Public Version
- 1
- Public Version Date
- 2018-10-22
- Public Version Status
- New
- Public Device Record Key
- 8fd5ac1e-33c8-4907-8639-e7577f795773
Device Description
Pack, Hot or Cold, Disposable
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00311960410304 | GS1 | ||||
| Package | 20311960410308 | GS1 | Inner Carton | 4 | In Commercial Distribution | |
| Package | 10311960410301 | GS1 | Master Carton-033107 | 4 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 9 | Inch | |
| Width | 6 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature