Catalog Number

PN-0004220

Brand Name

Tablo(R) Cartridge

Version/Model Number

PN-0006310

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

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

K190793,K190793

Product Code

FJK

Product Code Name

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

Public Device Record Key

d92ced8a-2bc0-46c0-8213-768e8400a952

Public Version Date

April 19, 2022

Public Version Number

1

DI Record Publish Date

April 11, 2022

Package DI Number

10850001011249

Quantity per Package

6

Contains DI Package

00850001011242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box