Catalog Number

-

Brand Name

APEX HP

Version/Model Number

APEX HP PHISIO/SMARxT

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083021,K083021

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Public Device Record Key

04b00850-5590-4d76-a67b-b64b2efa648f

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

July 15, 2015

Package DI Number

38033178109926

Quantity per Package

2

Contains DI Package

08033178109925

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX