FDA UDI
In Commercial Distribution
🇺🇸 United States
CareOne
DI: 00041520126641
·
Model: 041520126641
·
Ahold U.S.A., Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
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Basic Information
- Brand Name
- CareOne
- Primary DI
- 00041520126641
- Version / Model
- 041520126641
- Company Name
- Ahold U.S.A., Inc.
- Labeler DUNS
- 170199058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2019-06-28
- Public Version
- 2
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 1699745f-819f-4ba2-a2c8-fa11c6bfcaa2
Device Description
Shower Shield Clear Bandage Protector, all one size, 5 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
- 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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34832 | Waterproof skin adhesive tape | A long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10041520126648 | GS1 | case | 36 | In Commercial Distribution | |
| Primary | 00041520126641 | GS1 | ||||
| Unit of Use | 60041520126643 | GS1 |