Identity
- Trade Name
- Kent FAC-5 Class B 21 - 20118340 - Refill FDA UDI
- Generic Name
- First aid kit, medicated FDA UDI
- Device Name
- Kent FAC-5 Class B 21 - 20118340 - Refill FDA UDI
- Model / Reference
- KR622-089 FDA UDI
- Description
- Kent FAC-5 Class B 21 - 20118340 - Refill FDA UDI
Identifiers
- Catalog Number
- KR622-089 FDA UDI
- Primary DI / UDI-DI
- 00766588229898 FDA UDI
- 510(k) Number
- K940249 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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
Kent FAC-5 Class B 21 - 20118340 - Refill by Certified Safety Manufacturing, Inc. — Class N — 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
- 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
- OP - First aid series — Yiwu Ori-Power Medtech Co., Ltd. · N
Cleared under the same submission
K940249 also covers:
- 10M - Idaho Body Fluid — Certified Safety Manufacturing, Inc.
- 10PW - BloodBorne Pathogen — Certified Safety Manufacturing, Inc.
- 10PW - Hawaii School Bus — Certified Safety Manufacturing, Inc.
- 10PW - New Hampshire Body Fluid — Certified Safety Manufacturing, Inc.
- 10PW - New York School Bus — Certified Safety Manufacturing, Inc.
- 10PW - Tennessee Body Fluid — Certified Safety Manufacturing, Inc.
- 10PW - West Virginia Body Fluid — Certified Safety Manufacturing, Inc.
- 10R - Arizona Body Fluid - Refill — Certified Safety Manufacturing, Inc.
- 10R - Missouri BFK++ - Refill — Certified Safety Manufacturing, Inc.
- 10R - New Mexico Body Fluid - Refill — Certified Safety Manufacturing, Inc.
- 10R - Washington Body Fluid - Refill — Certified Safety Manufacturing, Inc.
- 16PW - BFK Kansas Truck Equip — Certified Safety Manufacturing, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI b041c6f3-7af8-446c-a719-ac674a42d33b 36 fields · synced May 30, 2026