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) (10)

Premarket Exempt

Clear

Quadrox D ECC Pack - 00607567201798 Catalog Number : 701052034

Device Description : BEQ-HMOD 70000-USA Adult Quadrox iD

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

QUADROX iD Pack - 00607567201828 Catalog Number : 701052285

Device Description : BEQ-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800ml,BEQ-RF32 RotaF BEQ-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800ml,BEQ-RF32 RotaFlow,Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

3/8 QiD pack w/Better Bladder - 00607567201859 Catalog Number : 701050228

Device Description : BEQ-HMOD 70000-USA Adult Quadrox iDSoftshell Venous Reser. 800mlBlood Transfer B BEQ-HMOD 70000-USA Adult Quadrox iDSoftshell Venous Reser. 800mlBlood Transfer Bag 1000 ml - 2 spike portsBEQ-RF32 RotaFlowBlood Microfilter System SQ 40 SPrebypass 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

Circulatory Circuit 3/8" - 00607567201866 Catalog Number : 701050859

Device Description : BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, BEQ-RF32 Ro BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Circulatory ECC - 00607567202016 Catalog Number : 701051791

Device Description : BEW HMOD 70000BEQ RF32BMY CEllArterial SensorGas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Small Patient CPS - 00607567202023 Catalog Number : 701052630

Device Description : BEQ-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800ml,CDI Sat Cell 3 BEQ-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800ml,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 : DWE

Prescription Use : Yes

Device Count : 1

Neonatal CPS + "QPiD" - 00607567202030 Catalog Number : 701052633

Device Description : BEQ-HMOD 30000-USA Pediatric Quadrox iD,Softshell Venous Reser. 800ml,CDI Sat Ce BEQ-HMOD 30000-USA Pediatric Quadrox iD,Softshell Venous Reser. 800ml,CDI Sat Cell 1/4" System 100,Blood Microfilter System SQ 40 S,Gas Filter,Pediatric Temp Probe

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Small Patient ECC Pack - 00607567202061 Catalog Number : 701049513

Device Description : BEQ- HMDOD 70000Soft Shell Venous Reser 800mLBetter Bladder 1/4BEQ RF 32 Rotaflo BEQ- HMDOD 70000Soft Shell Venous Reser 800mLBetter Bladder 1/4BEQ RF 32 RotaflowGas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Hemobag Adapter - 00607567202092 Catalog Number : 701053384

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Tubing Pack 1/4" with QPiD - 00607567202207 Catalog Number : 701051756

Device Description : BEQ-HMOD 30000-USA Pediatric Quadrox iDBlood Microfilter System SQ 40 SPediatric BEQ-HMOD 30000-USA Pediatric Quadrox iDBlood Microfilter System SQ 40 SPediatric Temp Probe

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

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