Catalog Number

-

Brand Name

Demax

Version/Model Number

DPY01B

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

99a8c392-575a-456b-87a2-2e50b4095521

Public Version Date

July 22, 2022

Public Version Number

1

DI Record Publish Date

July 14, 2022

Package DI Number

16943718213021

Quantity per Package

60

Contains DI Package

06943718213024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-