HarmonyAIR

Basic Information

• Brand Name: HarmonyAIR
• Primary DI: 00724995193782
• Version / Model: A-Series Non-Sterilizable Light Handle
• Catalog Number: LAS0038
• Company Name: STERIS CORPORATION
• Labeler DUNS: 036985604
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-28
• Public Version: 4
• Public Version Date: 2021-05-18
• Public Version Status: Update
• Public Device Record Key: da4f2b27-eaa0-46f2-a373-f5bc7dca7fb1
• Distribution End Date: 2021-05-18

Device Description

The Non-Sterilizable Plastic Light Handle is used with the HarmonyAIR A-Series Lighting 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
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44975	Medical equipment handle cover, reusable	A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a rigid polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995193782	GS1

Customer Contacts

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