MH100017

GUDID 10845854081686

2/CA SMOKESTAR 3 PORT FILTER

Conmed Corporation

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 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: 10845854081686
• NIH Device Record Key: a26ca952-a750-4bc5-adad-459886a45a66
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: MH100017
• Catalog Number: MH100017
• 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: 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: 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
• 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 Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845854081686 [Direct Marking]
GS1	30845854081680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930041

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: 2020-10-22
• Device Publish Date: 2020-10-14

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• 10653405004578 - NA: 2024-06-06 5-LEAD COMBINER
• 10653405004608 - NA: 2024-06-06 RE-ORDER TAG
• 10653405004622 - NA: 2024-06-06 ECG CABLES
• 10653405064220 - NA: 2024-06-06 ECG LEADWIRES
• 30845854080751 - PENADAPT: 2024-05-03 PenAdapt Electrosurgical Pencil Adapter 1 ft (30.5cm) tubing
• 30845854061767 - NA: 2024-05-03 EY Tubing Kit 1-3/8 in (35mm) x 6 ft (1.8m) tube and six 2 ft (.6m) tubes with integral wand & sponge guard
• 30845854045798 - CrossFT: 2024-04-26 CrossFT Knotless Biocomposite 4.0 mm Suture Anchor with one 2 mm Hi-Fi Tape (Blue)