Catalog Number

-

Brand Name

Centrisol Acid Concentrate

Version/Model Number

SB-342

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 17, 2018

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

933edc0e-82f1-4341-93d7-6d34a2f4bffb

Public Version Date

April 27, 2022

Public Version Number

7

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-