QUADROX-i - QUADROX-i Small Adult HMO 50000 + VHK 71000 - Maquet Cardiopulmonary AG

Duns Number:316153865

Device Description: QUADROX-i Small Adult HMO 50000 + VHK 71000 Oxygenator with venous hardshell cardiotomy re QUADROX-i Small Adult HMO 50000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoir, non-coated, vacuum-tight.

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More Product Details

Catalog Number

70106.7969

Brand Name

QUADROX-i

Version/Model Number

VKMO 51000 #SQUADROX-i HMO 51000+VHK7100

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

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

K132166

Product Code Details

Product Code

DTN

Product Code Name

RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

951167e2-7fc2-48ac-bef6-0c01ef543cfe

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

October 12, 2017

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