Identity
- Trade Name
- TopCare health FDA UDI
- Generic Name
- First aid kit, medicated FDA UDI
- Device Name
- 3-Step Wound Care Kit, 40 items: 10 - Gauze Pad 4 IN x 4 IN (101 mm x 101 mm); 10 - Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 12 - Non-Stick Pads 3 IN x 4 IN (76 mm x 101 mm); 4 - Transparent Dressings 2.36 IN x 2.75 IN (59 mm x 69 mm); 3 - Rolled Gauze 4 IN x 2.5 YDS (101 mm x 2.28 m); 1 - Paper Tape 1 IN x 10 YDS (25 mm x 9.14 m) FDA UDI
- Model / Reference
- 036800464933 FDA UDI
- Description
- 3-Step Wound Care Kit, 40 items: 10 - Gauze Pad 4 IN x 4 IN (101 mm x 101 mm); 10 - Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 12 - Non-Stick Pads 3 IN x 4 IN (76 mm x 101 mm); 4 - Transparent Dressings 2.36 IN x 2.75 IN (59 mm x 69 mm); 3 - Rolled Gauze 4 IN x 2.5 YDS (101 mm x 2.28 m); 1 - Paper Tape 1 IN x 10 YDS (25 mm x 9.14 m) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00036800464933 FDA UDI
- FDA Product Code
- LRR FDA UDI
- GMDN Term
- First aid kit, medicated FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: First aid kit, medicated
TopCare health by Topco Associates, LLC — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as First aid kit, medicated.
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- OP - First aid series — Yiwu Ori-Power Medtech Co., Ltd. · N
- HSB - National Standard Body Fluid — Certified Safety Manufacturing, Inc. · N
- First Aid Only — Acme United Corporation · N
- First Aid Only — ACME UNITED CORP. · N
- NAR — NORTH AMERICAN RESCUE, LLC.
- OP - First aid series — Yiwu Ori-Power Medtech Co., Ltd. · N
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Topco Associates, LLC
Sources (1)
- FDA UDI 807f2fc6-5e57-44a9-8c8c-1dc4950beab6 33 fields · synced Jun 8, 2026