Catalog Number

70105.5721

Brand Name

MAQUET CARDIOHELP

Version/Model Number

BS 3/8x1/16-1/4x3/32 L1.7

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133598

Product Code

DTQ

Product Code Name

Console, Heart-Lung Machine, Cardiopulmonary Bypass

Public Device Record Key

9c65dd3b-2a17-4d59-a18f-9cccf8736b8e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-