HarmonyAIR

Basic Information

• Brand Name: HarmonyAIR
• Primary DI: 00724995158408
• Version / Model: M-Series Suspension
• Catalog Number: LMH0010
• Company Name: STERIS CORPORATION
• Labeler DUNS: 036985604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-15
• Public Version: 2
• Public Version Date: 2021-01-27
• Public Version Status: Update
• Public Device Record Key: 8968215b-7d87-4cf6-b90f-d4578b10cd85

Device Description

The STERIS HD Light Handle Camera Module M-Series is used with the HarmonyAIR M-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
KQM	CAMERA, SURGICAL AND ACCESSORIES	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32265	Surgical video camera	An electro-optical device (e.g., a CCD) designed to obtain moving-picture documentation of an open surgical procedure. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995158408	GS1

Customer Contacts

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