Catalog Number

A-225

Brand Name

Tablo Hemodialysis Concentrate

Version/Model Number

PN-0000832

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

K843963,K843963

Product Code

FKQ

Product Code Name

System, Dialysate Delivery, Central Multiple Patient

Public Device Record Key

3ac382b0-8280-49fb-8701-d91359eaadc8

Public Version Date

November 02, 2020

Public Version Number

4

DI Record Publish Date

January 29, 2016

Package DI Number

10850001011041

Quantity per Package

4

Contains DI Package

00850001011044

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated carton