Catalog Number

114014

Brand Name

BiCart

Version/Model Number

1250

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

K013724,K013724

Product Code

KPO

Product Code Name

DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Public Device Record Key

0e453fa1-e69b-4d9d-9f0b-7f4f9ed7fcda

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

37332414110575

Quantity per Package

6

Contains DI Package

07332414110574

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE