Catalog Number

70104.9004

Brand Name

NA

Version/Model Number

Holder f. VKMO 10000/11000/30000/31000

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

-

Product Code

KRI

Product Code Name

ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Public Device Record Key

fae00640-55e2-45c7-8022-1b7b3b6a64f9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-