PFM MEDICAL 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

Vascular Access Port Kit (PXK) (10)

Premarket Exempt

No Yes

Clear

Jet Port - 00813623010390 Catalog Number : 616.021.0078-HAV

Device Description : 9.6F Jet Port Dual HP PUR Kit

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : PXK

Prescription Use : Yes

Device Count : 1

Tita Jet - 00813623010406 Catalog Number : 616.022.0078-HAV

Device Description : 9.6F Tita Jet Light Dual HP PUR Kit

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : PXK

Prescription Use : Yes

Device Count : 1

Tita Jet - 00813623010413 Catalog Number : 616.360.9070-HAV

Device Description : 4.8F Tita Jet Light Low Profile HP PUR Kit

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : PXK

Prescription Use : Yes

Device Count : 1

Tita Jet - 00813623010420 Catalog Number : 616.360.8070-HAV

Device Description : 6.6F Tita Jet Light Low Profile HP PUR Kit

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : PXK

Prescription Use : Yes

Device Count : 1

T-Port - 00813623010437 Catalog Number : 616.365.3078-HAV

Device Description : 6.6F T-Port HP PUR Kit

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : PXK

Prescription Use : Yes

Device Count : 1

T-Port - 00813623010444 Catalog Number : 616.365.2087-HAV

Device Description : 8F T-Port HP PUR Kit (non-filled)

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : PXK

Prescription Use : Yes

Device Count : 1

T-Port - 00813623010451 Catalog Number : 616.365.2088-HAV

Device Description : 8F T-Port HP PUR Kit (filled)

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : PXK

Prescription Use : Yes

Device Count : 1

T-Port - 00813623010468 Catalog Number : 616.366.3077-HAV

Device Description : 6.6F T-Port LP HP PUR Kit (non-filled)

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : PXK

Prescription Use : Yes

Device Count : 1

T-Port - 00813623010475 Catalog Number : 616.366.3078-HAV

Device Description : 6.6F T-Port LP HP PUR Kit (filled)

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : PXK

Prescription Use : Yes

Device Count : 1

T-Port - 00813623010482 Catalog Number : 616.366.2087-HAV

Device Description : 8F T-Port LP HP PUR Kit (non-filled)

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : PXK

Prescription Use : Yes

Device Count : 1

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