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) (8) Bottle, Collection, Vacuum (KDQ) (2)

Premarket Exempt

No Yes

Clear

Jet-Vac - 00813623040878 Catalog Number : M7098

Device Description : Jet-Vac Large Bore Drainage Line Set

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : KDQ

Prescription Use : Yes

Device Count : 1

Jet-Vac - 00813623040885 Catalog Number : M7097

Device Description : Jet-Vac Drainage Line Extension

Device Class : 2

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : KDQ

Prescription Use : Yes

Device Count : 1

Tita Jet Light - 07640110985465 Catalog Number :

Device Description : TJL Low Profile HP PUR Kit with 6.6F 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 - 07640110985472 Catalog Number :

Device Description : TJL Low Profile HP 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

Jet Port Plus - 07640110985489 Catalog Number :

Device Description : Jet Port Plus HP PUR Kit with 6.6F x 750 mm Pre-attached Polyurethane Catheter

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

T-Port - 07640110985496 Catalog Number :

Device Description : T-Port LP HP PUR Kit with 8F x 750 mm Pre-attached Polyurethane Catheter and Sil T-Port LP HP PUR Kit with 8F x 750 mm Pre-attached 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 - 07640110987247 Catalog Number :

Device Description : T-Port 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 - 07640110987254 Catalog Number :

Device Description : T-Port 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

T-Port - 07640110987476 Catalog Number :

Device Description : T-Port LP 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 - 07640110987506 Catalog Number :

Device Description : Jet Port Plus 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

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