Catalog Number

08-4078-BB

Brand Name

Bibag

Version/Model Number

08-4078-BB

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

KPO

Product Code Name

DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Public Device Record Key

97b22a64-2353-4010-ba24-eca78e320012

Public Version Date

March 16, 2020

Public Version Number

4

DI Record Publish Date

October 02, 2015

Package DI Number

10840861101310

Quantity per Package

16

Contains DI Package

00840861101313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-