Catalog Number

70100.5686

Brand Name

NA

Version/Model Number

Ven.Cath.,2-stage,reinf.,Bullet tip

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 31, 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

K013944,K013944

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Public Device Record Key

6a692b9d-3e96-42db-b8e3-4e02270de1c4

Public Version Date

August 05, 2022

Public Version Number

6

DI Record Publish Date

October 24, 2015

Package DI Number

04037691079585

Quantity per Package

10

Contains DI Package

04037691085104

Package Discontinue Date

January 31, 2020

Package Status

Not in Commercial Distribution

Package Type

-