NA

Basic Information

• Brand Name: NA
• Primary DI: 20845854061883
• Version / Model: QS0026
• Catalog Number: QS0026
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2020-09-10
• Public Version: 2
• Public Version Date: 2021-02-23
• Public Version Status: Update
• Public Device Record Key: aaa1bfc4-8bea-456d-a699-30e0940876c6
• Distribution End Date: 2021-02-23

Device Description

HarmonyAIR Smoke Evacuator Tubing

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: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAZ	TUBING, NONINVASIVE	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46483	Surgical plume evacuation system tube	A sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30845854061880	GS1	Box	12	Not in Commercial Distribution	2021-02-23
Primary	20845854061883	GS1
Unit of Use	00845854061889	GS1

Customer Contacts

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