FDA UDI
In Commercial Distribution
🇺🇸 United States
Kroger
DI: 00041260345470
·
Model: 041260345470
·
KROGER CO., THE
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
Basic Information
- Brand Name
- Kroger
- Primary DI
- 00041260345470
- Version / Model
- 041260345470
- Company Name
- KROGER CO., THE
- Labeler DUNS
- 006999528
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2020-08-07
- Public Version
- 1
- Public Version Date
- 2020-08-17
- Public Version Status
- New
- Public Device Record Key
- 294a836f-dc05-4832-8994-c93e6ff1acc0
Device Description
Heat Therapy Patches Back & Large Areas
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OMW | Adhesive Backed Thermal Skin Patches | Physical Medicine | 890.5710 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37697 | Exothermic heat therapy pack/patch | A device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. It includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated; it may be available in a variety of forms (e.g., adhesive patch, belt containing packs). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10041260345477 | GS1 | box | 24 | In Commercial Distribution | |
| Primary | 00041260345470 | GS1 | ||||
| Unit of Use | 60041260345472 | GS1 |
Customer Contacts
- Phone
- 18006326900
- [email protected]