Catalog Number

-

Brand Name

MPS Water Circuit Adapter, 16C

Version/Model Number

5161110

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

-

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

K173716

Product Code

DTR

Product Code Name

Heat-Exchanger, Cardiopulmonary Bypass

Public Device Record Key

ddc2a767-7793-42cf-84da-f17dbcd389e7

Public Version Date

April 16, 2021

Public Version Number

1

DI Record Publish Date

April 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-