FDA UDI
In Commercial Distribution
🇺🇸 United States
Green Guard Instant Cold Pack
DI: 00347682033002
·
Model: 3300
·
Greenguard
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Green Guard Instant Cold Pack
- Primary DI
- 00347682033002
- Version / Model
- 3300
- Catalog Number
- 3300
- 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
- 35cb9b89-397e-4cf8-9c34-6abd9aa4f2cc
Device Description
A device intended to be applied with pressure to the body surface to provide cold therapy - large
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 | 50347682033007 | GS1 | master case | 24 | In Commercial Distribution | |
| Primary | 00347682033002 | GS1 |
Customer Contacts
- Phone
- 1-800-869-6970
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature. Storage at cooler temperatures could cause frostbite after activation