FDA.reportPublic FDA data

QUADROX-i

Primary DI
04037692011362
Brand
QUADROX-i
Company
Maquet Cardiopulmonary AG
Model
Small Adult, reservoir
Catalog number
70106.7967
Published
2015-12-15
Public version status
Update
Distribution status
Not 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
JODFILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary BypassCardiovascular2

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
04037692011362PackageGS12Not in Commercial Distribution
04037692010006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04037692011362040376920113624037692011362
04037692010006040376920100064037692010006

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.

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
04037691831039AVALON ELITEVAK70106.35402016-01-13
04037691831046AVALON ELITEVAK70106.35392016-01-13
04037691730660NAPIK 10070105.30682015-11-04
04037691730677NAPIK 15070105.30692015-11-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04058863019222QUADROX-iMaquet Cardiopulmonary AGJOD2017-10-12
04037691838663VHK Venous ReservoirMaquet Cardiopulmonary AGJOD2017-03-13
04037691854984VHK reservoir AdMaquet Cardiopulmonary AGJOD2017-03-13
04058863007403QUADROX-iMaquet Cardiopulmonary AGJOD2017-02-16
04058863018843QUADROX-iMaquet Cardiopulmonary AGJOD2017-02-16
04058863005805QUADROX-iMaquet Cardiopulmonary AGJOD2017-02-15
04058863018867QUADROX-iMaquet Cardiopulmonary AGJOD2017-02-15
10887691000307Cardioplegia PlusHAEMONETICS CORPORATIONJOD2017-01-19
30887691000301Cardioplegia PlusHAEMONETICS CORPORATIONJOD2017-01-19
04037692010006QUADROX-iMaquet Cardiopulmonary AGJOD2015-12-15
04037692009987QUADROX-iMaquet Cardiopulmonary AGJOD2015-12-15
04037692009994QUADROX-iMaquet Cardiopulmonary AGJOD2015-12-15
04037692010013QUADROX-iMaquet Cardiopulmonary AGJOD2015-12-15
04037691833545NAMaquet Cardiopulmonary AGJOD2015-10-24
04037691906942QUADROX-iMaquet Cardiopulmonary AGJOD2015-10-24
04037691913032QUADROX-iMaquet Cardiopulmonary AGJOD2015-10-24
04037691965307QUADROX-iMaquet Cardiopulmonary AGJOD2015-10-24
04037691965628QUADROX-iMaquet Cardiopulmonary AGJOD2015-10-24