HarmonyAIR

Basic Information

• Brand Name: HarmonyAIR
• Primary DI: 10724995150119
• Version / Model: Smoke Evacuator Filter Fluid Trap
• Catalog Number: QS0027
• Company Name: STERIS CORPORATION
• Labeler DUNS: 036985604
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 11
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 84810f36-ad9c-4e34-b63c-4277cc76cd10
• Distribution End Date: 2020-12-22

Device Description

The HarmonyAIR Smoke Evacuator Filter Fluid Traps is a box of 10 filter fluid traps for the HarmonyAIR Smoke Evacuator that is designed to capture fluids to help maintain the integrity of the filtration system and assist with maintaining filter life.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
34858	Surgical suction system collection container, single-use	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10724995150119	GS1
Unit of Use	00724995150112	GS1

Customer Contacts

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