Catalog Number

DPC2023S500C

Brand Name

Pentair

Version/Model Number

701054385

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K982385,K982385

Product Code

KRJ

Product Code Name

Filter, Prebypass, Cardiopulmonary Bypass

Public Device Record Key

e3c4080f-1330-46b6-91d0-491aff7b8a1b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-