FDA.reportPublic FDA data

CARDIOTOMY RESERVOIR

Primary DI
38033178109674
Brand
CARDIOTOMY RESERVOIR
Company
SORIN GROUP ITALIA SRL
Model
UNFILTERED
Published
2015-07-15
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

Product Codes#

Code, Name table
CodeName
DTPDefoamer, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTPDefoamer, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902437000COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTERCobe Laboratories, Inc.1990-12-17DTP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178109674PackageGS16In Commercial Distribution
08033178109673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317810967438033178109674
08033178109673080331781096738033178109673

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

Regulatory Flags#

DUNS number
442126587
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
false
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
08033178018203Venous Cardiopolmunary Bypass CannulaRDS-610342025-12-19
08033178018227Venous Cardiopolmunary Bypass CannulaRDS-610402025-12-19
08033178018234Venous Cardiopolmunary Bypass CannulaRDS-610462025-12-19
08033178018258Venous Cardiopolmunary Bypass CannulaRDS-611342025-12-19
08033178018272Venous Cardiopolmunary Bypass CannulaRDS-611402025-12-19
08033178018289Venous Cardiopolmunary Bypass CannulaRDS-611462025-12-19
08033178018296Venous Cardiopolmunary Bypass CannulaRDS-611502025-12-19
08033178018364Venous Cardiopolmunary Bypass CannulaRV-400162025-12-19
08033178018371Venous Cardiopolmunary Bypass CannulaRV-400182025-12-19
08033178018388Venous Cardiopolmunary Bypass CannulaRV-400202025-12-19
08033178018395Venous Cardiopolmunary Bypass CannulaRV-400222025-12-19
08033178018401Venous Cardiopolmunary Bypass CannulaRV-400242025-12-19
08033178018418Venous Cardiopolmunary Bypass CannulaRV-400262025-12-19
08033178018425Venous Cardiopolmunary Bypass CannulaRV-400282025-12-19
08033178018432Venous Cardiopolmunary Bypass CannulaRV-400302025-12-19
08033178018449Venous Cardiopolmunary Bypass CannulaRV-400322025-12-19
08033178018456Venous Cardiopolmunary Bypass CannulaRV-400342025-12-19
08033178018463Venous Cardiopolmunary Bypass CannulaRV-400362025-12-19
08033178018487Venous Cardiopolmunary Bypass CannulaRV-405362025-12-19
08033178018524Venous Cardiopolmunary Bypass CannulaRV-410182025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033178113359INSPIRESORIN GROUP ITALIA SRLDTP2021-04-13
08033178113366INSPIRESORIN GROUP ITALIA SRLDTP2021-04-13
00699753450868NX19 Oxygenator w/4-liter reservoir; right-side outlet portTerumo Cardiovascular Systems CorporationDTP2021-03-18
00699753450875NX19 Oxygenator w/4-liter reservoir; left-side outlet portTerumo Cardiovascular Systems CorporationDTP2021-03-18
04058863019222QUADROX-iMaquet Cardiopulmonary AGDTP2017-10-12
04037691075051VBT Venous Bubble TrapMaquet Cardiopulmonary AGDTP2017-03-13
04037691075068VBT Venous Bubble TrapMaquet Cardiopulmonary AGDTP2017-03-13
04037691576350MACEMaquet Cardiopulmonary AGDTP2017-03-13
04037691665726MACEMaquet Cardiopulmonary AGDTP2017-03-13
04037691665733MACEMaquet Cardiopulmonary AGDTP2017-03-13
04037691838663VHK Venous ReservoirMaquet Cardiopulmonary AGDTP2017-03-13
04037691854984VHK reservoir AdMaquet Cardiopulmonary AGDTP2017-03-13
04058863017792Quadrox-iMaquet Cardiopulmonary AGDTP2017-03-13
04058863007403QUADROX-iMaquet Cardiopulmonary AGDTP2017-02-16
04058863018843QUADROX-iMaquet Cardiopulmonary AGDTP2017-02-16
04058863005805QUADROX-iMaquet Cardiopulmonary AGDTP2017-02-15
04058863018867QUADROX-iMaquet Cardiopulmonary AGDTP2017-02-15
00643169767645Intersept™MEDTRONIC, INC.DTP2017-02-05
B066H11360STANDARD VAVD KITNOVOSCI CORP.DTP2016-09-26
B066H11363Standard VAVD KitNOVOSCI CORP.DTP2016-09-26
04037692010006QUADROX-iMaquet Cardiopulmonary AGDTP2015-12-15
04037692009987QUADROX-iMaquet Cardiopulmonary AGDTP2015-12-15
04037692009994QUADROX-iMaquet Cardiopulmonary AGDTP2015-12-15
04037692010013QUADROX-iMaquet Cardiopulmonary AGDTP2015-12-15
04037691209722NAMaquet Cardiopulmonary AGDTP2015-10-24
04037691032528NAMaquet Cardiopulmonary AGDTP2015-10-24
04037691572758NAMaquet Cardiopulmonary AGDTP2015-10-24
04037691773414QUADROX-iMaquet Cardiopulmonary AGDTP2015-10-24
04037691775388QUADROX-iMaquet Cardiopulmonary AGDTP2015-10-24
04037691780139QUADROX-iMaquet Cardiopulmonary AGDTP2015-10-24