FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CVS Health
DI: 00050428616802
·
Model: 310381
·
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- CVS Health
- Primary DI
- 00050428616802
- Version / Model
- 310381
- Company Name
- WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Labeler DUNS
- 062312574
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-30
- Public Version
- 2
- Public Version Date
- 2026-04-30
- Public Version Status
- Update
- Public Device Record Key
- 45ef143b-a78c-44e8-a8e6-55cf85de3995
- Distribution End Date
- 2025-03-11
Device Description
3-Step Kit for Minor Burns, 6 pieces: gauze pads, hydrogel burn pads, rolled gauze.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| OJJ | Burn Kit Without Drug | General, Plastic Surgery | 878.4022 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10516 | Burn kit, non-medicated | A collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20050428616806 | GS1 | case | 18 | Not in Commercial Distribution | 2025-03-11 |
| Primary | 00050428616802 | GS1 |