Catalog Number

FAK-0025

Brand Name

OmniSafeTM

Version/Model Number

FAK-0025

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

9ad55fd9-9144-4b39-b7f9-9a6b76e210e2

Public Version Date

August 01, 2019

Public Version Number

1

DI Record Publish Date

July 24, 2019

Package DI Number

50810572002198

Quantity per Package

12

Contains DI Package

00810572002193

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton