FDA UDI
In Commercial Distribution
🇺🇸 United States
CARE SCIENCE
DI: 00017276238501
·
Model: 017276238501
·
Aso LLC
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
300
Basic Information
- Brand Name
- CARE SCIENCE
- Primary DI
- 00017276238501
- Version / Model
- 017276238501
- Company Name
- Aso LLC
- Labeler DUNS
- 152793493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 300
- Record Status
- Published
- Publish Date
- 2021-09-13
- Public Version
- 1
- Public Version Date
- 2021-09-21
- Public Version Status
- New
- Public Device Record Key
- b5e2192b-9616-48d5-9deb-365ce21d3567
Device Description
Individually boxed, Variety Pack Adhesive Bandages: Antibacterial Flexible Fabric Bandages: 30 - 3/4 IN x 3 IN (19 mm x 76 mm); Flexible Fabric Bandages: 26 - 5/8 IN x 2 1/4 IN (15 mm x 57 mm), 30 - 3/4 IN x 3 IN (19 mm x 76 mm), 16 - 1 IN x 3 IN (25 mm x 76 mm), 4 - 1 1/2 IN x 3 IN (38 mm x 76 mm), 4 - 1 3/4 IN x 2 IN (44 mm x 50 mm); Plastic Bandages: 60- 3/4 IN x 3 IN (19 mm x 76 mm); Sheer Bandages: 20- 7/8 IN (22 mm), 24 - 5/8 IN x 2 1/4 IN (15 mm x 57 mm), 30 - 3/4 IN x 3 IN (19 mm x 76 mm), 6 - 2 1/4 IN x 3 IN (57 mm x 76 mm); Strong Strips Bandages: 16- 1 IN x 3 1/4 IN (25 mm x 82 mm), 4 - 1 3/4 IN x 4 IN (44 mm x 101 mm); Watershield Plus Bandages: 30 - 1 IN x 2 1/2 IN (25 mm x 63 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
- 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 |
| 44990 | Skin-cover adhesive strip, non-antimicrobial | A small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. 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 | 20017276238505 | GS1 | case | 12 | In Commercial Distribution | |
| Primary | 00017276238501 | GS1 | ||||
| Unit of Use | 60017276238503 | GS1 |
Customer Contacts
- Phone
- 1-855-823-4545
- [email protected]