Catalog Number

CART-200

Brand Name

Tablo Cartridge

Version/Model Number

PN-0002305

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 03, 2020

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

K140841,K140841

Product Code

FJK

Product Code Name

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

Public Device Record Key

16e3788a-59da-4686-b9cb-14c4f1ed7f2c

Public Version Date

August 04, 2020

Public Version Number

6

DI Record Publish Date

April 11, 2017

Package DI Number

10850001011072

Quantity per Package

6

Contains DI Package

00850001011075

Package Discontinue Date

August 03, 2020

Package Status

Not in Commercial Distribution

Package Type

Carton