FDA UDI
In Commercial Distribution
🇺🇸 United States
TopCare health
DI: 00036800479463
·
Model: 036800479463
·
TOPCO ASSOCIATES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
120
Basic Information
- Brand Name
- TopCare health
- Primary DI
- 00036800479463
- Version / Model
- 036800479463
- Company Name
- TOPCO ASSOCIATES, LLC
- Labeler DUNS
- 072943876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 120
- Record Status
- Published
- Publish Date
- 2019-10-30
- Public Version
- 2
- Public Version Date
- 2020-08-07
- Public Version Status
- Update
- Public Device Record Key
- ca020898-72c8-4188-bce3-c1618c7970be
Device Description
Sterile, Antibacterial, Value Pack, Assorted Adhesive Bandages: Flexible Fabric: 2 IN x 4 IN (5.0 cm x 10.1 cm); 3/4 IN x 3 IN (1.9 cm x 7.6 cm). Variety Pack: Strong Strips: 1 IN x 3 1/4 IN (2.5 cm x 8.2 cm). Water Shield Plus: 1 IN x 2 1/2 IN (2.5 cm x 6.3 cm). Foam: 5/8 IN x 2 1/4 IN (1.5 cm x 5.7 cm). Water Shield Plus: 3/4 IN x 2 IN (1.9 cm x 5 cm); 1 IN x 2 1/2 IN (2.5 cm x 6.3 cm). Neon: 1 1/2 IN X 3 1/2 IN (3.8 cm X 8.8 cm); 3/4 IN X 3 IN (1.9 cm X 7.6 cm); 5/8 IN X 2 1/4 IN (1.5 cm X 5.7 cm).
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 | 10036800479460 | GS1 | case | 24 | In Commercial Distribution | |
| Primary | 00036800479463 | GS1 | ||||
| Unit of Use | 60036800479465 | GS1 |