Buffalo Filter

GUDID 20815198011158

Surgical Laser Mask

Buffalo Filter

Surgical/medical face mask, single-use

• Primary Device ID: 20815198011158
• NIH Device Record Key: 5d2ec3ec-c5d5-44c4-aa4c-ce23b4820731
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Buffalo Filter
• Version Model Number: SMLOF50
• Company DUNS: 787855907
• Company Name: Buffalo Filter
• Device Count: 50
• 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: true
• 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	00815198011154 [Unit of Use]
GS1	10815198011151 [Primary]
GS1	20815198011158 [Package]; Contains: 10815198011151; Package: case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930067

FDA Product Code

• FXX: Mask, 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: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-01-13

On-Brand Devices [Buffalo Filter]

• 20815198012704: Insufflation Tubing
• 10815198012660: Smoke Evacuation Tubing (Non-Sterile)
• 00815198012502: Direct Connect Cable
• 00815198012496: Direct Connect Cable
• 20815198012216: Insufflation Tubing
• 20815198012209: Insufflation Tubing
• 20815198012193: Insufflation Tubing
• 10815198012127: Televac Smoke Evacuation Filter Replacement
• 10815198011281: Smoke Evacuation Tubing with 8 in integral wand and sponge guard
• 00815198011253: Wall Plate for Suction Canister
• 10815198011229: Televac Smoke Evacuation Filter Replacement
• 10815198011205: Smoke Evacuation Filter
• 00815198011147: Ring Holder for Suction Canister
• 10815198011083: Smoke Evacuation Tubing with 7/8" to 3/8" reducer fitting
• 10815198011052: Smoke Evacuation Tubing with 8 in integral wand and sponge guard
• 10815198011038: Smoke Evacuation Tubing (Non-Sterile)
• 10851136002997: ULPA/Carbon Smoke Evacuation Filter Replacement
• 10851136002980: Smoke Evacuation Tubing with wand and sponge guard
• 00851136002969: Pneumatic Footswitch
• 10851136002942: Smoke Evacuation Tubing (Non-Sterile)
• 00851136002921: Electronic Footswitch
• 10851136002881: Smoke Evacuation Tubing
• 10851136002874: EDGE Smoke Evacuation Pre-Filter Replacement
• 10851136002843: Smoke Evacuation Tubing with wand and sponge guard
• 10851136002799: Smoke Evacuation Tubing (Non-Sterile)
• 10851136002775: Smoke Evacuation Tubing (Non-Sterile)
• 10851136002751: Replacement Pre-Filter for Stackhouse ES-2000 System
• 10851136002744: Smoke Evacuation Tubing
• 10851136002737: ULPA/Carbon Smoke Evacuation Pre-Filter Replacement
• 10851136002720: Tubing with 7/8" to 1/4" Reducer Fitting
• 10851136002706: Replacement Pre-Filter for Stackhouse ES-2000 System
• 10851136002676: Smoke Evacuation Tubing (Non-Sterile)
• 10851136002669: Laser & Electrosurgery In-Line Filter
• 10851136002652: Smoke Evacuation Tubing with wand and sponge guard
• 00851136002648: Replacement filter for Stackhouse ES-2000 System
• 00851136002631: Tubing stand/holder
• 10851136002577: Replacement Pre-Filter for Stackhouse ES-2000 System
• 00851136002556: Smoke Evacuation Tubing with 8 in integral wand and sponge guard and 7/8 in to 1-3/8 in adapter
• 10851136002539: Smoke Evacuation Tubing with integral wand and sponge guard
• 10851136002522: Smoke Evacuation Tubing with 8 in integral wand and sponge guard
• 10851136002515: Smoke Evacuation Tubing with integral wand and sponge guard
• 00851136002501: Laser Resistant Wand with Sponge Guard
• 20851136002482: Smoke Evacuation Tubing (Non-Sterile)
• 00851136002471: EDGE Smoke Evacuation Filter Replacement
• 10851136002461: Smoke Evacuation Tubing with 7/8 in to 1/4 in reducer
• 20851136002451: Laser & Electrosurgery Smoke Pre-Filter
• 10851136002447: ULPA/Carbon Smoke Evacuation Filter Replacement
• 00851136002365: Y Adapter 7/8" to 7/8"
• 10851136002355: Smoke Evacuation Tubing with 7/8 in to 1/4 in reducer
• 10851136002331: Speculum Tubing