PlumeSafe® X5™ PX5-120

GUDID 10653405987550

Smoke Evacuation Unit with PlumeSafe X5 Smoke Evacuation Filter

Conmed Corporation

Surgical plume evacuation system

• Primary Device ID: 10653405987550
• NIH Device Record Key: c58331c5-49b9-4d1a-9ba4-2a1b0156b300
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlumeSafe® X5™
• Version Model Number: PX5-120
• Catalog Number: PX5-120
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10653405987550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240127

FDA Product Code

• FYD: APPARATUS, EXHAUST, SURGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-20
• Device Publish Date: 2024-08-12

On-Brand Devices [PlumeSafe® X5™]

• 30653405988018: Filter, 1” (25 mm), 3/8” (9.5 mm), 1” (25 mm) Ports
• 30653405987561: Smoke Evacuation Unit
• 10653405988007: Filter, 1” (25 mm), 3/8” (9.5 mm), 1” (25 mm) Ports
• 10653405987994: Filter, 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports
• 10653405987550: Smoke Evacuation Unit with PlumeSafe X5 Smoke Evacuation Filter
• 30653405990196: Filter, 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports