Catalog Number

FAK-0010

Brand Name

OmniSafeTM

Version/Model Number

FAK-0010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LRR

Product Code Name

First Aid Kit with drug

Public Device Record Key

16928611-1aea-49b9-9d08-b3772bb0b088

Public Version Date

August 01, 2019

Public Version Number

1

DI Record Publish Date

July 24, 2019

Package DI Number

50810572002181

Quantity per Package

12

Contains DI Package

00810572002186

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton