Cardiohelp - CARDIOHELP mobile holder model HKH 8860. The - Maquet Cardiopulmonary AG

Duns Number:316153865

Device Description: CARDIOHELP mobile holder model HKH 8860. The CARDIOHELP Mobile Holder is for connecting th CARDIOHELP mobile holder model HKH 8860. The CARDIOHELP Mobile Holder is for connecting the CARDIOHELP Base Plate or CARDIOHELP Wall Holder incl. CARDIOHELP protection cover.

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More Product Details

Catalog Number

70107.3079

Brand Name

Cardiohelp

Version/Model Number

Mobile Holder HKH 8860

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K102726

Product Code Details

Product Code

DTQ

Product Code Name

CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

36a80d22-16a7-4375-b745-7b8d14760738

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAQUET CARDIOPULMONARY AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 286