Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

86125B

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

eeaac8c9-125e-4eda-9652-32a4e9236440

Public Version Date

October 13, 2022

Public Version Number

1

DI Record Publish Date

October 05, 2022

Package DI Number

20809160386849

Quantity per Package

20

Contains DI Package

10809160386842

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-