Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

81329C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 30, 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

LRS

Product Code Name

I.V. start kit

Public Device Record Key

6abfb25c-43cf-4be3-82dc-bba42518dcc0

Public Version Date

March 31, 2021

Public Version Number

2

DI Record Publish Date

January 13, 2021

Package DI Number

20809160342951

Quantity per Package

20

Contains DI Package

10809160342954

Package Discontinue Date

March 30, 2021

Package Status

Not in Commercial Distribution

Package Type

-