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EMPACT Active Shooter Tool Kit- Advanced Bleeding Control Kit- 10+ Patient
FDA UDIClass I (US FDA UDI)
by Pro1tek
Identity
- Trade Name
- EMPACT Active Shooter Tool Kit- Advanced Bleeding Control Kit- 10+ Patient FDA UDI
- Generic Name
- First aid kit, medicated FDA UDI
- Device Name
- EMPACT is an Emergency Medical Passive Active Shooter Countermeasure Tool Kit. Medical Trauma First Aid Advanced Bleeding Control Kit- 10+ Patient Kit with Tactical FDA UDI
- Model / Reference
- B283ELXB0 FDA UDI
- Description
- EMPACT is an Emergency Medical Passive Active Shooter Countermeasure Tool Kit. Medical Trauma First Aid Advanced Bleeding Control Kit- 10+ Patient Kit with Tactical FDA UDI
Identifiers
- Primary DI / UDI-DI
- B283ELXB0 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
Yes
FDA UDI
Over-the-Counter
No
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 Active Shooter Tool Kit- Advanced Bleeding Control Kit- 10+ Patient 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 b00128bc-63fb-41e8-8646-9d1a12812e32 34 fields · synced Jun 1, 2026