Catalog Number

-

Brand Name

NA

Version/Model Number

8888130556

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

b394a4fb-a760-4808-9757-43081a483ece

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

February 02, 2019

Package DI Number

10884521532199

Quantity per Package

20

Contains DI Package

10884521056299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE