Catalog Number

872.10

Brand Name

VYGON

Version/Model Number

872.10

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

-

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Public Device Record Key

31b27a59-e096-4b0e-827a-0f10792d7517

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

53660812009206

Quantity per Package

18

Contains DI Package

33660812009202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-