Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

79829B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 02, 2020

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

19051d43-a9b9-46d7-9a07-42a49dc46c4c

Public Version Date

September 03, 2020

Public Version Number

2

DI Record Publish Date

December 04, 2019

Package DI Number

20809160273545

Quantity per Package

20

Contains DI Package

10809160273548

Package Discontinue Date

September 02, 2020

Package Status

Not in Commercial Distribution

Package Type

-