MACE - Neonatal Venous Hardshell Cardiotomy Reservoir - Maquet Cardiopulmonary AG

Duns Number:316153865

Device Description: Neonatal Venous Hardshell Cardiotomy Reservoir (MACE) neonatal with SOFTLINE Coating, vacu Neonatal Venous Hardshell Cardiotomy Reservoir (MACE) neonatal with SOFTLINE Coating, vacuum-tight, Sterile. The Neonatal (VHK 11000) Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood. Both reservoirs are of identical design, differing only in the size, to enable the defined performance within flow rates, required for neonatal or pediatric patients. The reservoirs can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

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More Product Details

Catalog Number

70105.1430

Brand Name

MACE

Version/Model Number

BO-VHK 11000, SOFTLINE, Neonatal, Sterile

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

K141432

Product Code Details

Product Code

DTN

Product Code Name

RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

03f94b4c-8ef6-4101-91d5-2442e918ae23

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

March 13, 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