Catalog Number

MAP101/C

Brand Name

Passage®

Version/Model Number

00884450589939

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

94477e72-2beb-453a-8481-97f3660f64e6

Public Version Date

December 15, 2021

Public Version Number

1

DI Record Publish Date

December 07, 2021

Package DI Number

20884450589933

Quantity per Package

4

Contains DI Package

10884450589936

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-