DATASCOPE CORP.

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

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Filters

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

Adult Specialty Pack - 00060756720454 Catalog Number : 701062913

Device Description : BEQ-HMOD 70000-USA Adult Quadrox iD,FlowProbe Connector,Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

LVAD 1/4 - 00060756720676 Catalog Number : 701068168

Device Description : Softshell Venous Reser. 800ml,BEQ-RF32 RotaFlow,HPH 400,CDI Sat Cell 1/4" System Softshell Venous Reser. 800ml,BEQ-RF32 RotaFlow,HPH 400,CDI Sat Cell 1/4" System 100,Blood Microfilter System SQ 40 S,

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

6ft 1/4 x 3/32 Tubing 68A - 00607567200029 Catalog Number : 701048952

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

6ft 3/8 x 3/32 Tubing - 00607567200043 Catalog Number : 701048443

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

10ft 1/2 x 3/32 Tubing - 00607567200050 Catalog Number : 701048425

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

10ft 3/8 x 3/32 Tubing 68A - 00607567200067 Catalog Number : 701048448

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

6ft 1/4 x 1/16 Tubing - 00607567200074 Catalog Number : 701048431

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

10ft 1/2 x 3/32 Tubing - 00607567200081 Catalog Number : 701048424

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

6ft 1/2 x 3/32 Tubing - 00607567200098 Catalog Number : 701048422

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

6ft 3/8 x 3/32 Tubing 68A - 00607567200135 Catalog Number : 701048441

Device Description : Tubing only

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

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