Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

80391B

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

OHR

Product Code Name

Catheter care tray

Public Device Record Key

ad00a8da-30eb-4bc3-90a7-fa9728629373

Public Version Date

February 15, 2021

Public Version Number

1

DI Record Publish Date

February 05, 2021

Package DI Number

20809160345105

Quantity per Package

8

Contains DI Package

10809160345108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-