NA

Basic Information

• Brand Name: NA
• Primary DI: 30845854081680
• Version / Model: MH100017
• Catalog Number: MH100017
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-14
• Public Version: 3
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: a26ca952-a750-4bc5-adad-459886a45a66

Device Description

2/CA SMOKESTAR 3 PORT FILTER

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYD	APPARATUS, EXHAUST, SURGICAL	General, Plastic Surgery	878.5070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44979	Surgical plume evacuation system filter	A screening device designed for use with a surgical smoke evacuation system, to entrap particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent this from exhausting into the ambient air or evacuation tubing/pipeline systems. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs. This is a reusable device, typically with a limited lifetime (e.g., 5 hours, 20 procedures, or weekly exchange).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	10845854081686	GS1
Primary	30845854081680	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K930041	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -13 – 158 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 0 – 1 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY