LaparoVue

GUDID 20815198012247

LaparoVue Visibility System

Buffalo Filter

Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution

• Primary Device ID: 20815198012247
• NIH Device Record Key: b97bb027-a053-4c36-b7a6-bd359555b4b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LaparoVue
• Version Model Number: LAPVUE01
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815198012243 [Primary]
GS1	10815198012240 [Package]; Contains: 00815198012243; Package: Case [3 Units]; In Commercial Distribution
GS1	20815198012247 [Package]; Contains: 00815198012243; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150569

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-10
• Device Publish Date: 2016-09-23

Devices Manufactured by Buffalo Filter

• 10815198011045 - Buffalo Filter: 2022-04-22 Reducer Fitting 1-3/8" to 3/8"
• 10815198011069 - Buffalo Filter: 2022-04-22 Laser Resistant Wand with Sponge Guard
• 10815198011175 - Buffalo Filter: 2022-04-22 Sponge Guard
• 10815198011311 - Buffalo Filter: 2022-04-22 Reducer Fitting 7/8" to 1/4" with 2" cuff
• 20815198012636 - Cooper Surgical: 2022-04-22 Smoke Ecavuator Pre-Filter
• 10851136002287 - Buffalo Filter: 2022-04-22 Reducer Fitting 7/8" to 1/4"
• 10851136002317 - LaseAdapt: 2022-04-22 Reusable Clips
• 10851136002768 - Buffalo Filter: 2022-04-22 Laser Resistant Wand with Sponge Guard