Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

78608

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 14, 2021

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

cf03608c-1c37-4ec3-b0bd-a4d22a3a49da

Public Version Date

May 17, 2021

Public Version Number

4

DI Record Publish Date

March 05, 2019

Package DI Number

20809160230142

Quantity per Package

10

Contains DI Package

10809160230145

Package Discontinue Date

May 14, 2021

Package Status

Not in Commercial Distribution

Package Type

-