Quadrox-i

Primary DI
04058863017792
Brand
Quadrox-i
Company
Maquet Cardiopulmonary AG
Model
SQUADROX-i HMO 70000+ VHK7000
Catalog number
70106.7941
Device description
Quadrox-i Hollow Membrane Oxygenator, Adult, with VHK Reservior, unsealed, with Universal Adaptor, without Filter; vacuum-tight, non-Coated, Sterile. The QUADROX-i Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter. They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature.
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
GODAntigens, Cf (Including Cf Control), Adenovirus 1-33

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2
DTPDefoamer, Cardiopulmonary BypassCardiovascular2
GODAntigens, Cf (Including Cf Control), Adenovirus 1-33Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132166000VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTMaquet Cardiopulmonary, AG2013-10-30DTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058863017792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058863017792040588630177924058863017792

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal membrane oxygenatorA device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume335Milliliter
Weight2.93Kilogram

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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