Smoke Evacuator Filter

Basic Information

• Brand Name: Smoke Evacuator Filter
• Primary DI: 00609960001326
• Version / Model: EV-I/R
• Catalog Number: EV-I/R
• Company Name: DERMATOLOGIC LAB AND SUPPLY, INC.
• Labeler DUNS: 021628771
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-30
• Public Version: 1
• Public Version Date: 2020-10-08
• Public Version Status: New
• Public Device Record Key: b43e940d-6096-4641-9ba9-100996f9efb6

Device Description

FILTERS, ONLY, VIRAL,SMOKE EVACUATOR, 1 EACH. Medical Device.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
Primary	00609960001326	GS1