Catalog Number

-

Brand Name

Medical Action Industries Inc

Version/Model Number

79299B

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"

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

a609ef35-8778-410b-aa87-c161b3a5ac10

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

November 20, 2019

Package DI Number

20809160271756

Quantity per Package

10

Contains DI Package

10809160271759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-