Catalog Number

CART-100

Brand Name

Tablo Cartridge

Version/Model Number

DWG-3008

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

K140841,K140841

Product Code

FJK

Product Code Name

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

Public Device Record Key

bf24d426-f8ad-4465-abec-5b14d3ebb89e

Public Version Date

June 07, 2019

Public Version Number

5

DI Record Publish Date

October 23, 2015

Package DI Number

10850001011010

Quantity per Package

6

Contains DI Package

00850001011013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton