Catalog Number

-

Brand Name

Delivery Set 16C w/ AA 35cm Line

Version/Model Number

5161102

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

K953838,K953838

Product Code

DTR

Product Code Name

Heat-Exchanger, Cardiopulmonary Bypass

Public Device Record Key

76e421f7-7e56-4044-9ef2-4b44814a33da

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

February 02, 2018

Package DI Number

20634624561124

Quantity per Package

10

Contains DI Package

00634624561120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-