TELEFLEX INCORPORATED

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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

Catheter, intravascular, therapeutic, long-term greater than 30 days (LJS) (3) CATHETER, HEMODIALYSIS, NON-IMPLANTED (MPB) (1)

Premarket Exempt

No Yes

Clear

ARROW - 80801902123288 Catalog Number : AK-12142-F

Device Description : Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions

Device Class : 2

Duns Number: 002348191

Premarket Exempt : No

Product Code : MPB

Prescription Use : Yes

Device Count : 1

ARROW - 80801902123455 Catalog Number : CDC-05552-HPK1A

Device Description : Pressure Injectable Two-Lumen PICC

Device Class : 2

Duns Number: 002348191

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

ARROW - 80801902123745 Catalog Number : CDC-35052-VPS

Device Description : Arrow(R) PICC powered by Arrow(R) VPS(R) Stylet

Device Class : 2

Duns Number: 002348191

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

ARROW - 80801902123813 Catalog Number : CDC-35563-HPK1A

Device Description : ARROW(R) PICC

Device Class : 2

Duns Number: 002348191

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

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