PEMCO INC

Address:5663 BRECKSVILLE RD.,Cleveland,OH,44131,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

Sucker, Cardiotomy Return, Cardiopulmonary Bypass (DTS) (10)

Premarket Exempt

Yes

Clear

PEMCO INC - B152145017L0 Catalog Number : 1450-17L

Device Description : Pediatric Intracardiac Sucker Tip - 2.0 mm diameter, Long. For use with the Rou

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450900 Catalog Number : 1450-90

Device Description : Intracardiac Sucker Set with four Tips - Round, Adult Handle at 90 Degree Angle.

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450JR0 Catalog Number : 1450JR

Device Description : Intracardiac Sucker Set with two Tips – Round, Pediatric Handle at 30 Degree Ang

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450JR010 Catalog Number : 1450JR-01

Device Description : Intracardiac Sucker, Pediatric Round Handle at 30 Degree Angle has 3/8" barbed e

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450JR01900 Catalog Number : 1450JR-01-90

Device Description : Intracardiac Sucker, Pediatric Round Handle at 90 Degree Angle has 3/8" barbed e

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450JR900 Catalog Number : 1450JR-90

Device Description : Intracardiac Sucker Set with two Tips – Round, Pediatric Handle at 90 Degree Ang

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B15214600 Catalog Number : 1460

Device Description : Intracardiac Sucker: Flat, Pediatric Handle Fixed Tip, 3.2 mm diameter. Handle

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B15214700 Catalog Number : 1470

Device Description : Intracardiac Sucker: Flat, Pediatric Handle Fixed Tip, 4.7 mm diameter. Handle

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521470JR0 Catalog Number : 1470JR

Device Description : Intracardiac Sucker Set with two Tips – Round, Pediatric Flat at 40 Degree Angle

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521470JR010 Catalog Number : 1470JR-01

Device Description : Intracardiac Sucker, Pediatric Flat Handle at 40 Degree Angle has 5/16" barbed e

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

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