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Ifak

FDA UDI

Class I (US FDA UDI)

by Faretec, Inc.

Identity

Trade Name
IFAK FDA UDI
Generic Name
First aid kit, non-medicated, single-use FDA UDI
Device Name
Active Shooter Response Kit, custom FDA UDI
Model / Reference
Active Shooter Response Kit FDA UDI
Description
Active Shooter Response Kit, custom FDA UDI

Identifiers

Catalog Number
5000010 FDA UDI
Primary DI / UDI-DI
B54150000100 FDA UDI
FDA Product Code
OHO FDA UDI
GMDN Term
First aid kit, non-medicated, single-use 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: First aid kit, non-medicated, single-use

Ifak by Faretec, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as First aid kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Faretec, Inc.

Sources (1)

  • FDA UDI 7c254a8e-8791-4dd5-8889-440a268ba376 35 fields · synced May 30, 2026