PEMCO INC

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 - B15214500 Catalog Number : 1450

Device Description : Intracardiac Sucker Set with four Tips - Round, Adult Handle at 30 Degree Angle.

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450010 Catalog Number : 1450-01

Device Description : Intracardiac Sucker, Adult Round Handle at 30 Degree Angle, has 3/8" & 1/2" barb

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B152145001900 Catalog Number : 1450-01-90

Device Description : Intracardiac Sucker, Adult Round Handle at 90 Degree Angle has 3/8" & 1/2" barbe

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450050 Catalog Number : 1450-05

Device Description : Adult Intracardiac Sucker Tip - 10.5 mm diameter. Tips are grooved and slotted

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450060 Catalog Number : 1450-06

Device Description : Adult Intracardiac Sucker Tip - 8.8 mm diameter. Tips are grooved and slotted t

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450070 Catalog Number : 1450-07

Device Description : Adult Intracardiac Sucker Tip - 8.0 mm diameter. Tips are grooved and slotted t

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450080 Catalog Number : 1450-08

Device Description : Adult Intracardiac Sucker Tip - 6.4 mm diameter. Tips are grooved and slotted t

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450150 Catalog Number : 1450-15

Device Description : Pediatric Intracardiac Sucker Tip - 6.4 mm diameter. Tips are grooved and slott

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450160 Catalog Number : 1450-16

Device Description : Pediatric Intracardiac Sucker Tip - 4.0 mm diameter. For use with the Round Ped

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521450170 Catalog Number : 1450-17

Device Description : Pediatric Intracardiac Sucker Tip - 2.0 mm diameter. For use with the Round Ped

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

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