Catalog Number

-

Brand Name

CombiSet SMARTECH

Version/Model Number

03-2742-9C

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

K201207,K201207

Product Code

FJK

Product Code Name

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

Public Device Record Key

d356f3bd-386a-4ad7-8385-83323af908ab

Public Version Date

November 25, 2020

Public Version Number

1

DI Record Publish Date

November 17, 2020

Package DI Number

10840861102256

Quantity per Package

24

Contains DI Package

00840861102259

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case