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

Port & Catheter, Implanted, Subcutaneous, Intravascular (LJT) (10)

Premarket Exempt

No Yes

Clear

Tita Jet Light - 07640110987513 Catalog Number :

Device Description : Tita Jet Light PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

T-Port - 07640110987537 Catalog Number :

Device Description : T-Port PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

Jet Port Plus - 07640110987643 Catalog Number :

Device Description : Jet Port Plus Silicone Kit HF with 8.4F x 750 mm Attachable Silicone Catheter

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

Low Profile Peripheral - 07640110987704 Catalog Number :

Device Description : Low Profile Peripheral Silicone Kit with 6.6F x 750 mm Attachable Silicone Catheter

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

Low Profile Peripheral - 07640110987728 Catalog Number :

Device Description : Low Profile Peripheral PUR Kit with 4.8F x 750 mm Attachable Polyurethane Catheter

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

Low Profile Peripheral - 07640110987742 Catalog Number :

Device Description : Low Profile Peripheral Silicone Kit with 8.4F x 750 mm Attachable Silicone Catheter

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

Jet Port Plus II - 07640110987940 Catalog Number :

Device Description : Jet Port Plus II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

Tita Jet Light II - 07640110987988 Catalog Number :

Device Description : Tita Jet Light II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

T-Port - 07640110988336 Catalog Number :

Device Description : T-Port HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

T-Port - 07640110988350 Catalog Number :

Device Description : T-Port HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

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