Catalog Number

MAP152/F

Brand Name

AccessPLUS™

Version/Model Number

00884450590379

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

2a910600-477e-4853-8478-87d280a73664

Public Version Date

December 13, 2021

Public Version Number

1

DI Record Publish Date

December 03, 2021

Package DI Number

20884450590373

Quantity per Package

4

Contains DI Package

10884450590376

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-