HarmonyAIR

Basic Information

• Brand Name: HarmonyAIR
• Primary DI: 20845854081812
• Version / Model: QS0027
• Catalog Number: QS0027
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-09-11
• Public Version: 2
• Public Version Date: 2023-01-18
• Public Version Status: Update
• Public Device Record Key: 123bdd7d-57df-44a2-84d3-5fb071325608
• Distribution End Date: 2023-01-17

Device Description

HARMONYAIR FLUID TRAP, STERIS

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: Yes
• 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
GAZ	TUBING, NONINVASIVE	General Hospital	880.6740	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	30845854081819	GS1	BOX	10	Not in Commercial Distribution	2023-01-17
Primary	20845854081812	GS1
Unit of Use	00845854081818	GS1
Previous	10724995150119	GS1

Customer Contacts

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