Catalog Number

-

Brand Name

PRIMO2X

Version/Model Number

PRIMO2X M

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

K050447,K050447

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Public Device Record Key

0dd836da-e67d-4c4b-92ca-3aa4acd3c14e

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

July 15, 2015

Package DI Number

38033178100718

Quantity per Package

2

Contains DI Package

08033178100717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX