Catalog Number

BP2/3 - BP9/10

Brand Name

DIASOL

Version/Model Number

BP10000- 25G / x25T

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

K020230,K020230,K020230,K020230

Product Code

KPO

Product Code Name

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Public Device Record Key

55aa7210-d0bb-4a50-84dc-8df951718f46

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 28, 2017

Package DI Number

B467BP4525G3

Quantity per Package

3

Contains DI Package

B467BP4525

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE