FDA.reportPublic FDA data

RESERVOIR

Primary DI
08033178250160
Brand
RESERVOIR
Company
SORIN GROUP ITALIA SRL
Model
D744 D.A.C.
Published
2015-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K844803000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844803000POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTEElectromedics, Inc.1985-04-29DTP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178250161PackageGS18In Commercial Distribution
08033178250160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317825016138033178250161
08033178250160080331782501608033178250160

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.

Regulatory Flags#

DUNS number
442126587
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033178102933DHF02 HEMOCONCENTRATOR2015-07-15
08033178102940DHF06 HEMOCONCENTRATOR2015-07-15
08033178109062CSC 14CSC14 + PURGE LINE2015-07-10
08033178112253INSPIRE6M2015-05-13
08033178112277INSPIRE6F M2015-05-13
08033178112284INSPIRE8F M2015-05-13
08033178112291INSPIREHVR2015-05-13
08033178112307INSPIREHVR DUAL2015-05-13
08033178112352INSPIRE6 PH.I.S.I.O.2015-05-13
08033178112369INSPIRE8 PH.I.S.I.O.2015-05-13
08033178112376INSPIRE6F PH.I.S.I.O.2015-05-13
08033178112383INSPIRE8F PH.I.S.I.O.2015-05-13
08033178112390INSPIRE6 DUAL PH.I.S.I.O.2015-05-13
08033178112406INSPIRE8 DUAL PH.I.S.I.O.2015-05-13
08033178112413INSPIRE6F DUAL PH.I.S.I.O.2015-05-13
08033178112420INSPIRE8F DUAL PH.I.S.I.O.2015-05-13
08033178113014INSPIRESVR 12002017-03-29
08033178113182INSPIRE7 M2019-08-28
08033178113212INSPIRE72019-08-28
08033178113236INSPIRE7 DUAL2019-08-28

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