ViroSafe

GUDID 10851136002713

Erbium-YAG Smoke Evacuation Pre-Filter

Buffalo 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