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

CB Support Pack (Tubing Pack) - 00607567201224 Catalog Number : 701048556

Device Description : BEQ-RF32 RotaFlow,Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

ECC 3/8 AV Loop w Quadrox-iD - 00607567201484 Catalog Number : 701052461

Device Description : BEQ-HMOD 70000-USA Adult Quadrox iDSoftshell Venous Reser. 800mlBetter Bladder 3 BEQ-HMOD 70000-USA Adult Quadrox iDSoftshell Venous Reser. 800mlBetter Bladder 3/8CDI Sat Cell 3/8" System 100Prebypass filter w/o Vent Porous Media 3/8x3/8Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Sm. Patient Circuit 1/4" w/QD - 00607567201576 Catalog Number : 701053486

Device Description : BO-HMOD 70000Better BladderBO-RF32 RotaFlowGas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Veno - Veno Pack - 00607567201583 Catalog Number : 701053314

Device Description : VHK 71000 Venous Reservoir - uncoated, BEQ-RF32 RotaFlow,

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

UAMC Pediatric ECC Pack - 00607567201590 Catalog Number : 701051515

Device Description : BEQ-HMOD 30000-USA Pediatric Quadrox iDBEQ-RF32 RotaFlowCDI Sat Cell 1/4" System BEQ-HMOD 30000-USA Pediatric Quadrox iDBEQ-RF32 RotaFlowCDI Sat Cell 1/4" System 100Gas FilterPediatric Temp Probe

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Sm Patient ECC Pack QPiD - 00607567201606 Catalog Number : 701050839

Device Description : BEQ-HMOD 30000Blood Transfer Bag 1000mLBetter Bladder 1/4BEQ RF 32CDI Sat Cell 1 BEQ-HMOD 30000Blood Transfer Bag 1000mLBetter Bladder 1/4BEQ RF 32CDI Sat Cell 1/4"Prebypass Filter with out vent porous media 3/8 by 3/8Pediatric Temp Probe

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Sm. Patient Circuit - 00607567201613 Catalog Number : 701050966

Device Description : HMOD 70000Better BladderBO-RF 32Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Descending Thoracic Pack - 00607567201750 Catalog Number : 701049506

Device Description : BEQ-RF32 RotaFlow

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Descending Thoracic Pack - 00607567201774 Catalog Number : 701051272

Device Description : BO-RF32 RotaFlow

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Medical City Children's ECC 1/4" - 00607567201781 Catalog Number : 701050307

Device Description : Softshell Venous Reser. 800ml,Blood Transfer Bag 1000 ml - 2 spike ports,BEQ-RF3 Softshell Venous Reser. 800ml,Blood Transfer Bag 1000 ml - 2 spike ports,BEQ-RF32 RotaFlow,CDI Sat Cell 1/4" System 100,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

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