FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CareOne
DI: 00041520104861
·
Model: 041520104861
·
Ahold U.S.A., Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- CareOne
- Primary DI
- 00041520104861
- Version / Model
- 041520104861
- Company Name
- Ahold U.S.A., Inc.
- Labeler DUNS
- 170199058
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-07-31
- Public Version
- 4
- Public Version Date
- 2021-08-17
- Public Version Status
- Update
- Public Device Record Key
- 995ce6fe-6983-4bed-83b7-2f42c51ddc01
- Distribution End Date
- 2021-01-07
Device Description
Hydrocolloid Blister Cushion, all one size, 1.65 IN x 2.67 IN (42 mm x 68 mm)
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
- 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 |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61945 | Corn/callus dressing, single-use | An adhesive dressing intended for protection of corns or calluses (hardened areas of skin on the feet or toes) or unopened blisters, and to maintain a moist environment to allow the lesion to heal. It consists of a pad of material (e.g., hydrocolloid) and may be impregnated with an acid (e.g., salicylic) which acts as a keratolytic agent to facilitate the removal of dead skin. It may be supplied with another dressing (e.g., ring) to provide additional protection/cushioning around the lesion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10041520104868 | GS1 | case | 24 | Not in Commercial Distribution | 2021-01-07 |
| Primary | 00041520104861 | GS1 | ||||
| Unit of Use | 60041520104863 | GS1 |