ViroSafe

GUDID 10851136002713

Erbium-YAG Smoke Evacuation Pre-Filter

Buffalo Filter

Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter Surgical plume evacuation system filter

• Primary Device ID: 10851136002713
• NIH Device Record Key: f04663c1-73e1-4ee3-891a-a7b43ff0ffa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViroSafe
• Version Model Number: BFEY04PF
• Company DUNS: 787855907
• Company Name: Buffalo Filter
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com
• Phone: 716-835-7000
• Email: bf.smoke.info@buffalofilter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851136002716 [Primary]
GS1	10851136002713 [Package]; Contains: 00851136002716; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983298

FDA Product Code

• FYD: Apparatus, Exhaust, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [ViroSafe ]

• 10851136002867: Smoke Evacuation Filter - Dual male ports 7/8 in (22 mm) and 1-1/4 (32 mm)
• 10851136002713: Erbium-YAG Smoke Evacuation Pre-Filter
• 10851136002690: Smoke Evacuation Pre-Filter with 7/8" connectors
• 00851136002198: Erbium-YAG Smoke Evacuation Kit: 4 each 00851136002716 Pre-Filters and 1 each 00851136002181 Fi
• 00851136002181: Erbium-YAG Smoke Evacuation Filter
• 20851136002031: Extra Long Life Smoke Evacuation Filter - Dual male ports 7/8 in (22 mm) and 1-1/4 (32 mm)
• 20851136002024: Extra Long Life Smoke Evacuation Filter - Twin male ports 7/8 in (22 mm)
• 20851136002192: Erbium YAG Filter 00851136002181 and four Erbium YAG Pre-filters 00851136002715