DATASCOPE CORP.

Address:1300 Macarthur Blvd,MAHWAH,NJ,07430,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) (8) Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (1)

Premarket Exempt

Clear

10 ft 1/4 x 1/16 Tubing - 00607567200142 Catalog Number : 701048437

Device Description : Tubing only

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

6ft x 1/4 x 1/16 Tubing - 00607567200159 Catalog Number : 701048429

Device Class :

Duns Number: 001660786

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

6ft 1/2 x 3/32 Tubing - 00607567200166 Catalog Number : 701048418

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Standard Cardioplegia Line - 00607567200173 Catalog Number : 701047159

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

1/4" Circulatory Circuit - 00607567200234 Catalog Number : 701048138

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Tubing Pack - 00607567200296 Catalog Number : 701047379

Device Description : BEQ-HMOD 700000BEQ-RF32CDI Sat Cell 3/8"Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

UAMC Adult ECC Pack - 00607567200371 Catalog Number : 701050692

Device Description : BEQ-HMOD 7000BEQ-RF32 RotaFLowCDI Sat Cell 1/2" System 100Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Child ECC Quadrox iD with RF 3/8" - 00607567200395 Catalog Number : 701050060

Device Description : BEQ HMOD 70000Soft Shell Venous Rser 800 mlBlood Transfer Bag 1000 mlBEQ-RF32 Ro BEQ HMOD 70000Soft Shell Venous Rser 800 mlBlood Transfer Bag 1000 mlBEQ-RF32 RotaflowCDI Sat Cell 3/8"Blood Microfilter SystPrebypass FilterGas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

Adult CPB Pack with VKMO 71000 - 00607567200418 Catalog Number : 701051874

Device Description : HMO 71000 (BO coated) Quadrox i Adult with integral filter,BO-VHK 71000 Venous HMO 71000 (BO coated) Quadrox i Adult with integral filter,BO-VHK 71000 Venous Reservoir,Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Circulatory Circuit SM Patient - 00607567200449 Catalog Number : 701048539

Device Description : BEQ RF 32Gas Filter

Device Class : 2

Duns Number: 001660786

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

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