Catalog Number

PT420-0022C

Brand Name

Lexus

Version/Model Number

PT420-0022C

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

ce59fdf9-5105-4656-88a3-fb77613d047c

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Package DI Number

10816058012516

Quantity per Package

1

Contains DI Package

00816058012519

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag