Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

79270

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 09, 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

16413c3a-879c-439a-a0ff-a750076d7b2f

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

July 02, 2019

Package DI Number

20809160245177

Quantity per Package

20

Contains DI Package

10809160245170

Package Discontinue Date

June 09, 2022

Package Status

Not in Commercial Distribution

Package Type

-