FDA UDI
In Commercial Distribution
🇺🇸 United States
BAND-AID Brand Adhesive Bandages
DI: 00381371192533
·
Model: 00381371192533
·
Kenvue Brands LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BAND-AID Brand Adhesive Bandages
- Primary DI
- 00381371192533
- Version / Model
- 00381371192533
- Company Name
- Kenvue Brands LLC
- Labeler DUNS
- 118772437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-01
- Public Version
- 4
- Public Version Date
- 2024-11-04
- Public Version Status
- Update
- Public Device Record Key
- a3c43274-2f86-4177-94db-44ad1d965b39
Device Description
Band-Aid Infection Defense Large Adhesive Cover 6 Count
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
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 |
|---|---|---|---|---|---|---|
| Primary | 00381371192533 | GS1 |
Customer Contacts
- Phone
- +1(866)565-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K954007 | 000 |