FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Core Values
DI: 00017276236668
·
Model: 017276236668
·
HARMON STORES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Core Values
- Primary DI
- 00017276236668
- Version / Model
- 017276236668
- Company Name
- HARMON STORES, INC.
- Labeler DUNS
- 804085293
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-20
- Public Version
- 2
- Public Version Date
- 2023-05-16
- Public Version Status
- Update
- Public Device Record Key
- cb86d47d-ccab-4351-b2aa-6c4ce5b9ac30
- Distribution End Date
- 2022-12-20
Device Description
Wound Care Kit, Value Pack, 25 items, assorted sizes: 8 - Gauze Pads 4 IN x 4 IN (101 mm x 101 mm); 4 - Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 4 - Non-stick Pads 2 IN x 3 IN (50 mm x 76 mm); 4 - Non-stick Pads 3 IN x 4 IN (76 mm x 101 mm); 4 - Rolled Gauze 4 IN x 2.5 YDS (101 mm x 2.28 m); 1 – Paper Tape 1 IN x 10 YD (25 mm x 9.14 m).
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHO | First Aid Kit Without Drug | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44047 | First aid kit, non-medicated, single-use | A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10017276236665 | GS1 | case | 36 | Not in Commercial Distribution | 2022-12-20 |
| Primary | 00017276236668 | GS1 |