Catalog Number

A-125

Brand Name

Tablo Hemodialysis Concentrate

Version/Model Number

PN-0002630

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

K190793,K190793

Product Code

FJK

Product Code Name

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Public Device Record Key

40d033c1-4a84-493c-bb04-572626d688dc

Public Version Date

August 11, 2020

Public Version Number

1

DI Record Publish Date

August 03, 2020

Package DI Number

10850001011102

Quantity per Package

4

Contains DI Package

00850001011105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carboard box