Catalog Number

B-100

Brand Name

Tablo Hemodialysis Concentrate

Version/Model Number

PN-0000831

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

-

Product Code

KPO

Product Code Name

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Public Device Record Key

2d9c6fb7-4508-4a51-a40f-6bb098781c1c

Public Version Date

February 13, 2019

Public Version Number

3

DI Record Publish Date

January 29, 2016

Package DI Number

10850001011034

Quantity per Package

4

Contains DI Package

00850001011037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated carton