HarmonyAIR

Basic Information

• Brand Name: HarmonyAIR
• Primary DI: 00724995170479
• Version / Model: G-Series Suspension
• Catalog Number: LK00015
• Company Name: STERIS CORPORATION
• Labeler DUNS: 036985604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-19
• Public Version: 3
• Public Version Date: 2021-01-27
• Public Version Status: Update
• Public Device Record Key: 2fe0ea43-3fee-4c33-8eea-5cbbec851c17

Device Description

The Dual Spindle Light Head with Video 1750mm Single Flat Panel Monitor 1600mm G-Series 11008906 is used with the HarmonyAIR G-Series Suspension System.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
FQO	TABLE, OPERATING-ROOM, AC-POWERED	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32245	Medical monitor/light mount	A permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995170479	GS1

Customer Contacts

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