MACE

Primary DI
04037691665733
Brand
MACE
Company
Maquet Cardiopulmonary AG
Model
BO-VHK 31000 Paediatric SOFTLINE
Catalog number
70105.1432
Device description
Venous Hardshell Cardiotomy Reservoir (MACE) for pediatrics with SOFTLINE Coating, vacuum-tight, Sterile. The Paediatric (VHK 31000) 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 paediatric patients.The reservoirs can also be employed postoperatively as drainage and auto-transfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.
Published
2017-03-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTNRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
DTPDefoamer, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2
DTPDefoamer, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141432000NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSHMaquet Cardiopulmonary, AG2014-07-07DTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04037691665733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04037691665733040376916657334037691665733

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotomy reservoirA device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pore Size64Micrometer
Total Volume1700Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49072229320info.cp@maquet.com

Regulatory Flags#

DUNS number
316153865
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04037691650326ROTAFLOWCentrifugal Pump, SOFTLINE70104.75532015-10-30
04037691645148NACARDIOHELP Emergency Drive holder, Rail70104.93042016-02-29
04037691645155NACARDIOHELP Emergency Drive Holder, Mast70104.80062016-02-29
04037691720791NACARDIOHELP Holder for mast HKH 9102-M70104.95842016-02-29
04037691456584NAWall holder HKH 882070104.53662016-02-29
04037691717968NACardiohelp Mobile Holder HKH 886070105.08972016-02-29
04037691718330NAGas bottle holder f. helicopter HKH 888070105.09012016-02-29
04058863084336CardiohelpMobile Holder HKH 886070107.3079 2018-03-01
04037691075051VBT Venous Bubble TrapBEQ-VBT 160, BIOLINE, Sterile70103.08842017-03-13
04037691209722NAVBT Venous Bubble Trap70102.98052015-10-24
04037691349251BMU 40"BMU 40 Cell 1/2"""70104.08042016-01-18
04037691349268BMU 40"BMU 40 Cell 3/8"""70104.08442016-01-18
04037691349275BMU 40"BMU 40 Cell 1/4"""70104.08452016-01-18
04037691349282BMU 40"BMU 40 Sensor 3/8"""70104.08492016-01-18
04037691349299BMU 40"BMU 40 Sensor 1/4"""70104.08502016-01-18
04037691349305BMU 40"BMU 40 Sensor 3/16"""70104.08512016-01-18
04037691670164QUADROX-iPediatric, diffusion, BIOLINE70105.03302015-10-24
04037691770970QUADROX-iPediatric, filter70105.52152015-10-24
04058863017341QUADROX-iHMO 71000-USA #SQUADROX-i Adult + Coating, Filter70106.78232017-02-16
04058863017372QUADROX-iBEQ-HMO 71000-USA #SQUADROX-i Adult+BIOLINE +Filte70106.78292017-02-16

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