Catalog Number

MAP112/D

Brand Name

Access-9™

Version/Model Number

00884450590195

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)

-

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

c4e19a24-503a-4a66-af9f-989404bf432c

Public Version Date

April 06, 2022

Public Version Number

1

DI Record Publish Date

March 29, 2022

Package DI Number

20884450590199

Quantity per Package

4

Contains DI Package

10884450590192

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-