ViroSafe VisiClear Filter

Basic Information

• Brand Name: ViroSafe VisiClear Filter
• Primary DI: 00815198012052
• Version / Model: VS135
• Company Name: Buffalo Filter
• Labeler DUNS: 787855907
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2022-04-22
• Public Version Status: Update
• Public Device Record Key: 0faf307c-a874-4c0e-9768-a783e4119081
• Distribution End Date: 2022-04-21

Device Description

Smoke Evacuation Filter - 3-port 1/4 in (6.4mm), 3/8 in (9.5 mm), and 7/8 in (22 mm)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
Package	20815198012056	GS1	Case	4	Not in Commercial Distribution	2022-04-21
Primary	00815198012052	GS1
Package	10815198012059	GS1	Case	2	Not in Commercial Distribution	2022-04-21

Customer Contacts

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