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EMPACT 6+ Patient Hard Case Kit with Wall Cabinet
FDA UDIClass I (US FDA UDI)
by Pro1tek
Identity
- Trade Name
- EMPACT 6+ Patient Hard Case Kit with Wall Cabinet FDA UDI
- Generic Name
- First aid kit, medicated FDA UDI
- Device Name
- EMPACT 6+ Patient Hard Case Kit with Wall Cabinet - 6+ Patient Kit with Bat Flashlight contains both Medical and Tactical devices. Tactical helps with the run, hit fit in an active shooter situation. Kit features Hemostatic Dressing and other bleeding control devices and supplies to help in a trauma situation. FDA UDI
- Model / Reference
- B28300 FDA UDI
- Description
- EMPACT 6+ Patient Hard Case Kit with Wall Cabinet - 6+ Patient Kit with Bat Flashlight contains both Medical and Tactical devices. Tactical helps with the run, hit fit in an active shooter situation. Kit features Hemostatic Dressing and other bleeding control devices and supplies to help in a trauma situation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B28300 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
No
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
Yes
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 Hard Case Kit with Wall Cabinet 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 a7948a74-de93-47f8-8b76-b55dfe1ab96d 33 fields · synced May 30, 2026