Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

80653

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 16, 2017

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

23a0da23-97de-4e0b-8e2d-4938cfe374d3

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

April 05, 2017

Package DI Number

20809160144265

Quantity per Package

20

Contains DI Package

10809160144268

Package Discontinue Date

November 16, 2017

Package Status

Not in Commercial Distribution

Package Type

-