Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

79828

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 21, 2022

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OWL

Product Code Name

Peripheral catheter insertion kit

Public Device Record Key

a198ee4a-3e3a-4f36-9abe-9252c35b1276

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

December 13, 2019

Package DI Number

20809160274085

Quantity per Package

20

Contains DI Package

10809160274088

Package Discontinue Date

March 21, 2022

Package Status

Not in Commercial Distribution

Package Type

-