Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

79113D

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

0726c7d0-2db5-472a-a681-168bea03e207

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Package DI Number

20809160384241

Quantity per Package

20

Contains DI Package

10809160384244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-