Catalog Number

ACG2

Brand Name

DIASOL

Version/Model Number

100015-75200

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

383edbd0-5420-4a8e-90bd-2cd88ea87b6a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

B467100015752004

Quantity per Package

4

Contains DI Package

B46710001575200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE