Catalog Number

-

Brand Name

Dry Acid Dissolution Unit

Version/Model Number

160147

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)

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

1eb95446-0553-4bb1-bd10-50554625ec84

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 02, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-