Catalog Number

-

Brand Name

Assy, Venous Drainage, Cannula Conversion, 3/8

Version/Model Number

AX-xxxxx

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

K833322,K833322

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Public Device Record Key

88e23cdb-2b7d-4808-9d0b-e0e61f55e700

Public Version Date

August 15, 2018

Public Version Number

4

DI Record Publish Date

September 22, 2015

Package DI Number

10803622128384

Quantity per Package

10

Contains DI Package

00803622128387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE