FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CareOne
DI: 00041520875754
·
Model: 041520875754
·
Ahold U.S.A., Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- CareOne
- Primary DI
- 00041520875754
- Version / Model
- 041520875754
- Company Name
- Ahold U.S.A., Inc.
- Labeler DUNS
- 170199058
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-06-28
- Public Version
- 3
- Public Version Date
- 2026-04-29
- Public Version Status
- Update
- Public Device Record Key
- bf152738-6b87-4cb5-9585-1975be86fbcc
- Distribution End Date
- 2025-02-25
Device Description
Clear XL Waterproof Strong Strip Bandages Antibacterial, all one size, 2 IN x 4 IN
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47378 | Skin-cover adhesive strip, antimicrobial | A small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10041520975758 | GS1 | case | 72 | Not in Commercial Distribution | 2025-02-25 |
| Primary | 00041520875754 | GS1 | ||||
| Unit of Use | 60041520875756 | GS1 |