Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

81286

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

PEV

Product Code Name

Dialysis administration kit

Public Device Record Key

2d26e261-93ff-47fb-a0b6-1a59946a0eba

Public Version Date

January 05, 2021

Public Version Number

1

DI Record Publish Date

December 28, 2020

Package DI Number

20809160341787

Quantity per Package

20

Contains DI Package

10809160341780

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-