Buffalo Filter

Address:95 CORPORATE DRIVE,Trumbull,CT,06611,US

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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

Apparatus, Exhaust, Surgical (FYD) (6) Tubing, Noninvasive (GAZ) (2) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1) Tubing/Tubing With Filter, Insufflation, Laparoscopic (NKC) (1)

Premarket Exempt

No Yes

Clear

Buffalo Filter - 00815198012502 Catalog Number :

Device Description : Direct Connect Cable

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

PenAdapt - 00815198012519 Catalog Number :

Device Description : Electrosurgery Pencil Adaptor

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

TeleVac2 - 00815198012526 Catalog Number :

Device Description : Start-Up Kit with the following components: Multi-Port ULPA Filter - 0081519801 Start-Up Kit with the following components: Multi-Port ULPA Filter - 00815198012489, Footswitch - 00851136002969, EZLink - 00815198011079, Reducer Fitting - 00851136002976, Smoke Evacuation Tubing with Connectors - 00851136002150, Y-Adapter - 00851136002365, PlumePort SE - 00851136002433, PlumePort SEV - 00851136002587, Smoke Evacuation Tubing - 00851136002235, PenAdapt - 00851136002143, and Smoke Evacuation Tubing with Wand - 00851136002068

Device Class : 2

Duns Number: 787855907

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

ViroSafe ViroVac Filter - 00815198012533 Catalog Number :

Device Description : Smoke Evacuation Filter - 3-port 1/4 in (6.4mm), 3/8 in (9.5 mm), and 7/8 in (22 mm)

Device Class :

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

PlumePen - 00815198012601 Catalog Number : PROTIP500

Device Description : Disposable Capture Port Tip for Smoke Plume Electrosurgical Pencil

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Cooper Surgical - 00815198012649 Catalog Number : CPR-395703

Device Description : ULPA Charcoal Filter for the MiniVac Smoke Evacuator

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

Cooper Surgical - 00815198012656 Catalog Number : 6082

Device Description : ULPA Smoke Evacuator Filter

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

Buffalo Filter - 00815198012663 Catalog Number :

Device Description : Smoke Evacuation Tubing (Non-Sterile)

Device Class : 2

Duns Number: 787855907

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

Buffalo Filter - 00815198012700 Catalog Number : ITS152201

Device Description : Insufflation Tubing

Device Class :

Duns Number: 787855907

Premarket Exempt : Yes

Product Code : NKC

Prescription Use : Yes

Device Count : 1

Invuity - 00815198012717 Catalog Number : PB1SE

Device Description : PhotonBlade Smoke Evacuator

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

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