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EMPACT 6+ Patient Trauma Kit with Batons-OTC
FDA UDIClass I (US FDA UDI)
by Pro1tek
Identity
- Trade Name
- EMPACT 6+ Patient Trauma Kit with Batons-OTC FDA UDI
- Generic Name
- First aid kit, medicated FDA UDI
- Device Name
- EMPACT 6+ Patient Hart Case Kit with Batons and Extra Hemostatic Dressing. Tactical & Medical Trauma Kit. Tactical side Has Batons, TAC-Wedge, TAC-Keys and other Tactical components that can be used in an active shooter RUN, HIDE, FIGHT situation. Medical side has OTC Bleeding Control Kits featuring extra Hemostatic Dressing and other Trauma First-Aid equipment . FDA UDI
- Model / Reference
- B283E6HCXOC0 FDA UDI
- Description
- EMPACT 6+ Patient Hart Case Kit with Batons and Extra Hemostatic Dressing. Tactical & Medical Trauma Kit. Tactical side Has Batons, TAC-Wedge, TAC-Keys and other Tactical components that can be used in an active shooter RUN, HIDE, FIGHT situation. Medical side has OTC Bleeding Control Kits featuring extra Hemostatic Dressing and other Trauma First-Aid equipment . FDA UDI
Identifiers
- Primary DI / UDI-DI
- B283E6HCXOC0 FDA UDI
- FDA Product Code
- OVR FDA UDI
- GMDN Term
- First aid kit, medicated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4014 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: First aid kit, medicated
EMPACT 6+ Patient Trauma Kit with Batons-OTC by Pro1tek — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as First aid kit, medicated.
- OP - First aid series — Yiwu Ori-Power Medtech Co., Ltd. · N
- American Red Cross — ACME UNITED CORP. · N
- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Pro1tek
Sources (1)
- FDA UDI 1ac94a0f-1882-4970-a199-6672459fb8a8 33 fields · synced May 30, 2026