QUADROX-i

Primary DI
04037691770987
Brand
QUADROX-i
Company
Maquet Cardiopulmonary AG
Model
Pediatric, filter
Catalog number
70105.5215
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTMFilter, blood, cardiopulmonary bypass, arterial line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial LineCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132829000QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSMaquet Cardiopulmonary, AG2013-10-08DTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04037691770987PackageGS14In Commercial Distribution
04037691770970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04037691770987040376917709874037691770987
04037691770970040376917709704037691770970

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
316153865
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054117372446TRILLYEUROSETS SRLDTM2026-05-05
08054117372545HORIZONEUROSETS SRLDTM2026-05-05
B00962623OCS HEART LEUKOCYTE DEPLETING FILTERTRANSMEDICS, INC.DTM2026-05-04
08033178112857KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178112871KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178114561MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178114578MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178114608MICROSORIN GROUP ITALIA SRLDTM2025-03-04
38033178114562MICROSORIN GROUP ITALIA SRLDTM2025-03-04
38033178114579MICROSORIN GROUP ITALIA SRLDTM2025-03-04
38033178114609MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178113342INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
08033178113359INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
08033178113366INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
38033178113343INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
04037691180038PLEGIOX Heat Exchanger with CardioplegiaMaquet Cardiopulmonary AGDTM2017-05-02
04037691253862QUARTMaquet Cardiopulmonary AGDTM2017-03-13
04037691173412QUARTMaquet Cardiopulmonary AGDTM2017-03-13
04037691117911QUARTMaquet Cardiopulmonary AGDTM2017-03-13
04037691229591PLEGIOX Cardioplegia Heat Exchanger Maquet Cardiopulmonary AGDTM2017-03-13
04058863017341QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863017372QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019055QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019079QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019147QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019185QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019000QUADROX-iDMaquet Cardiopulmonary AGDTM2017-02-16
04058863019024QUADROX-iDMaquet Cardiopulmonary AGDTM2017-02-16
04058863019154QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019178QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16