Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

78791

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

8397aa84-bac3-41cd-b91f-fbbad82465a5

Public Version Date

June 19, 2019

Public Version Number

1

DI Record Publish Date

June 11, 2019

Package DI Number

20809160242558

Quantity per Package

20

Contains DI Package

10809160242551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-