PEMCO INC

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

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (7) Sucker, Cardiotomy Return, Cardiopulmonary Bypass (DTS) (3)

Premarket Exempt

Yes

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PEMCO INC - B15214800 Catalog Number : 1480

Device Description : Intracardiac Sucker Set with four Tips - Round, Flat Handle at 40 Degree Angle. Intracardiac Sucker Set with four Tips - Round, Flat Handle at 40 Degree Angle. Comes with Adult Tips 1450-05 10.5 mm diameter, 1450-06 8.8 mm diameter, 1450-07 8.0 mm diameter, 1450-08 6.4 mm diameter; can also use 1480-03 7.0 mm diameter tip. NOTE: All tips also fit 1480-04 sucker handle. Tips are grooved and slotted to allow for better flow and prevent clogging. Suckers have 5/16" barbed end. * Handles and tips may be ordered as separate items.

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521480030 Catalog Number : 1480-03

Device Description : Intracardiac Sucker Tip, 7.0 mm diameter. Tips are grooved and slotted to allow Intracardiac Sucker Tip, 7.0 mm diameter. Tips are grooved and slotted to allow for better flow and prevent clogging.For use with the Round Adult Handle 30 Degree Angle (1450-01), the Round Adult Handle 90 Degree Angle (1450-01-90) OR the Flat Adult Handle (1480-04)

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521480040 Catalog Number : 1480-04

Device Description : Intracardiac Sucker, Adult Flat Handle at 40 Degree Angle, has 5/16" barbed end. Intracardiac Sucker, Adult Flat Handle at 40 Degree Angle, has 5/16" barbed end. Works with the following tips Tips 1450-05 10.5 mm diameter, 1450-06 8.8 mm diameter, 1450-07 8.0 mm diameter, 1450-08 6.4 mm diameter, & 1480-03 7.0 mm diameter tip.

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DTS

Prescription Use : No

Device Count : 1

PEMCO INC - B1521580A012MM00 Catalog Number : 1580-A-01-2MM-0

Device Description : Perfusion Cannula. Large Handle 8.5 inches long. Style # 1 Fixed Tip with side Perfusion Cannula. Large Handle 8.5 inches long. Style # 1 Fixed Tip with side holes - 2 MM Tip Diameter. Zero Degree Bend.Also available in: Flag, Small, & Tube Handle Styles

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DWF

Prescription Use : No

Device Count : 1

PEMCO INC - B1521580A013MM00 Catalog Number : 1580-A-01-3MM-0

Device Description : Perfusion Cannula. Large Handle 8.5 inches long. Style # 1 Fixed Tip with side Perfusion Cannula. Large Handle 8.5 inches long. Style # 1 Fixed Tip with side holes - 3 MM Tip Diameter. Zero Degree Bend.Also available in: Flag, Small, & Tube Handle Styles

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DWF

Prescription Use : No

Device Count : 1

PEMCO INC - B1521580A014MM00 Catalog Number : 1580-A-01-4MM-0

Device Description : Perfusion Cannula. Large Handle 9.5 inches long. Style # 1 Fixed Tip with side Perfusion Cannula. Large Handle 9.5 inches long. Style # 1 Fixed Tip with side holes - 4 MM Tip Diameter. Zero Degree Bend.Also available in: Flag, Small, & Tube Handle Styles

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DWF

Prescription Use : No

Device Count : 1

PEMCO INC - B1521580A015MM00 Catalog Number : 1580-A-01-5MM-0

Device Description : Perfusion Cannula. Large Handle 9.5 inches long. Style # 1 Fixed Tip with side Perfusion Cannula. Large Handle 9.5 inches long. Style # 1 Fixed Tip with side holes - 5 MM Tip Diameter. Zero Degree Bend.Also available in: Flag, Small, & Tube Handle Styles

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DWF

Prescription Use : No

Device Count : 1

PEMCO INC - B1521580A022MM750 Catalog Number : 1580-A-02-2MM-75

Device Description : Perfusion Cannula. Large Handle 8.5 inches long. Style # 2 Swivel Tip with sid Perfusion Cannula. Large Handle 8.5 inches long. Style # 2 Swivel Tip with side holes - 2 MM Tip Diameter. 75 Degree Bend.Also available in: Flag, Small, & Tube Handle Styles

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DWF

Prescription Use : No

Device Count : 1

PEMCO INC - B1521580A023MM750 Catalog Number : 1580-A-02-3MM-75

Device Description : Perfusion Cannula. Large Handle 8.5 inches long. Style # 2 Swivel Tip with sid Perfusion Cannula. Large Handle 8.5 inches long. Style # 2 Swivel Tip with side holes - 3 MM Tip Diameter. 75 Degree Bend.Also available in: Flag, Small, & Tube Handle Styles

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DWF

Prescription Use : No

Device Count : 1

PEMCO INC - B1521580A024MM750 Catalog Number : 1580-A-02-4MM-75

Device Description : Perfusion Cannula. Large Handle 9.5 inches long. Style # 2 Swivel Tip with sid Perfusion Cannula. Large Handle 9.5 inches long. Style # 2 Swivel Tip with side holes - 4 MM Tip Diameter. 75 Degree Bend.Also available in: Flag, Small, & Tube Handle Styles

Device Class : 2

Duns Number: 004217071

Premarket Exempt : Yes

Product Code : DWF

Prescription Use : No

Device Count : 1

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