Catalog Number

5M8005A

Brand Name

ACID CONCENTRATE

Version/Model Number

5M8005A

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

K090002,K090002

Product Code

KPO

Product Code Name

DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Public Device Record Key

0dca578d-f9ca-42c7-9833-4b6fa99234dc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

50085412150616

Quantity per Package

4

Contains DI Package

00085412150611

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE