Catalog Number

ACG35

Brand Name

DIASOL

Version/Model Number

100025-75100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K851431,K851431,K851431

Product Code

KPO

Product Code Name

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Public Device Record Key

b090a57b-dced-4cca-841f-4d34a03858df

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 14, 2017

Package DI Number

B467100025751004

Quantity per Package

4

Contains DI Package

B46710002575100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE