FDA UDI
In Commercial Distribution
🇺🇸 United States
TopCare health
DI: 00036800259720
·
Model: 036800259720
·
TOPCO ASSOCIATES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
Basic Information
- Brand Name
- TopCare health
- Primary DI
- 00036800259720
- Version / Model
- 036800259720
- Company Name
- TOPCO ASSOCIATES, LLC
- Labeler DUNS
- 072943876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2019-10-30
- Public Version
- 1
- Public Version Date
- 2019-11-07
- Public Version Status
- New
- Public Device Record Key
- 7eff1ffc-e2b3-4a48-a388-be90d40964be
Device Description
Waterproof Shower Shield Clear Bandage Protector, 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 | 10036800259727 | GS1 | case | 36 | In Commercial Distribution | |
| Primary | 00036800259720 | GS1 | ||||
| Unit of Use | 60036800259722 | GS1 |