DATASCOPE CORP.

Address:15 Law Dr,FAIRFIELD,NJ,07004,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tubing, Pump, Cardiopulmonary Bypass (DWE) (8) Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (2)

Premarket Exempt

Clear

Circulatory Circuit - 00607567200463 Catalog Number : 701047118

Device Description : BEQ-HMOD 70000-USA Adult QuadroxGas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

CPS Tubing Pack - 00607567200470 Catalog Number : 701048690

Device Description : BEQ-HMOD 70000-USA Adult Quadrox iDBEQ-RF32 RotaFlowGas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

3/8 ECC Pack - 00607567200647 Catalog Number :

Device Description : BEQ -HMOD 70000-USA Adult Quadrox iDBEQ-RF32 RotaFLowCDI Sat Cell 3/8" System SQ BEQ -HMOD 70000-USA Adult Quadrox iDBEQ-RF32 RotaFLowCDI Sat Cell 3/8" System SQ 40 SGas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Small Patient Tubing Pack - 00607567200661 Catalog Number : 70104994

Device Description : Softshell Venous Reser. 1900ml with connectorBlood Transfer Bag 1000 ml 2 spike Softshell Venous Reser. 1900ml with connectorBlood Transfer Bag 1000 ml 2 spike portsBetter Bladder 1/4BEQ-RF32 RotaFlowPrebypass filter w/o Vent Porous Media 3/8x1/2Gas FIlterPediatric Temp Probe

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Tubing Pack - 00607567200760 Catalog Number : 701049510

Device Description : BEQ-HMOD 70000-USA Adult Quadrox iDBlood Microfilter System SQ 40 S

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Adult CPB Pack - 00607567200968 Catalog Number : 701052579

Device Description : HMO 71000 QuadroxBO-VHK 71000Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Adult ECC Pack with Quadrox iD - 00607567201095 Catalog Number : 701049524

Device Description : BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladd BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Sm Patient ECC Pack w/Quad iD - 00607567201101 Catalog Number : 701049526

Device Description : BEQ-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800ml,Better Bladder BEQ-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800ml,Better Bladder 1/4,BEQ-RF32 RotaFlow,Blood Microfilter System SQ 40 S,Prebypass filter w/o Vent Porous Media 3/8x3/8,Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Tubing Pack, 3/8" - 00607567201149 Catalog Number : 701051751

Device Description : BO-HMOD 70000-USA Adult Quadrox iD,Better Bladder 3/8,HPH 700,CDI Sat Cell 3/8" BO-HMOD 70000-USA Adult Quadrox iD,Better Bladder 3/8,HPH 700,CDI Sat Cell 3/8" System 100,Blood Microfilter System SQ 40 S,Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Open Heart Pack - 00607567201194 Catalog Number : 701052489

Device Description : BE-HMO 71000VHK 71000BEQ-RF32BC 60 PlusBMU CEllPrebypass FilterBacteria FilterGas Fileter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

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