Catalog Number

-

Brand Name

Centrisol Bicarbonate Concentrate Powder

Version/Model Number

MB-330-25

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K843963,K843963

Product Code

FKQ

Product Code Name

System, Dialysate Delivery, Central Multiple Patient

Public Device Record Key

a51ef370-7a60-4449-86a8-31e32516b267

Public Version Date

April 27, 2022

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

30677964000325

Quantity per Package

2

Contains DI Package

00677964000324

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case