Smoke Set

Basic Information

• Brand Name: Smoke Set
• Primary DI: 15060120959710
• Version / Model: 2200/47BDKBTUA123/0001
• Catalog Number: 2200/47BDK
• Company Name: GVS FILTER TECHNOLOGY UK LTD
• Labeler DUNS: 769934225
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-01
• Public Version: 2
• Public Version Date: 2026-02-02
• Public Version Status: Update
• Public Device Record Key: 826ca8a0-a750-4696-8c87-87e6e31a733e

Device Description

The combination particle and gas filter is used as part of a smoke evacuation system which reduces particulate and odour causing noxious chemicals from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision. It is indicated for use during any minimally invasive surgery involving insufflation, laser, or ultrasonic scalpel use. It is recommended that the surgeon and their team wear N95/FFP3 face mask during surgery.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
31723	Suction system filter, plume particulate	A screening device installed within the suction tubing line of a suction system, or the suction tubing used with a central vacuum system, to extract 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 clogging of the suction or vacuum system. 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 and can be made of translucent plastic, allowing for inspection when in use. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060120959710	GS1