Catalog Number

70101.0858

Brand Name

MAQUET HL20

Version/Model Number

BSC 20-500

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

K943803

Product Code

DTQ

Product Code Name

Console, Heart-Lung Machine, Cardiopulmonary Bypass

Public Device Record Key

16f39190-e56d-41cd-a73f-446fe8a747e2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-