Catalog Number

-

Brand Name

Centrisol Acid Concentrate

Version/Model Number

SB-353

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

Product Code

FKQ

Product Code Name

System, Dialysate Delivery, Central Multiple Patient

Public Device Record Key

2dbebd50-3fb7-4d98-b6a9-d2f9b111b049

Public Version Date

April 27, 2022

Public Version Number

4

DI Record Publish Date

July 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-