AccessGUDID - DEVICE: HarmonyAIR (10724995150300)

GUDID

Device Identifier (DI) Information

Brand Name: HarmonyAIR
Version or Model: E-Series
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LG0056
Company Name: STERIS CORPORATION

Primary DI Number: 10724995150300
Issuing Agency: GS1
Commercial Distribution End Date: January 24, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The HarmonyAIR Mobile Stand with G-Series Lighthead with metal crate is designed to provide a flexible, mobile lighting system for various surgical and diagnostic procedures in healthcare environments.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12282	Operating room light	A device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.	Active	false
42513	Transportable medical equipment stand, non-powered	A non-powered (non-active) transportable device [e.g., on wheels or easily movable] designed to support medical equipment (e.g., monitors, pumps, consoles) used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It may include manually-adjustable articulated arms to enable dynamic positioning of equipment; the equipment to be supported is not included. The device does not include a battery pack but might include a battery holder and electrical connection wiring to feed power to medical equipment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSS	Light, surgical, floor standing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c07f556-9b45-414b-8c6f-c2601db9c1a8
Public Version Date: February 03, 2025
Public Version Number: 8
DI Record Publish Date: May 19, 2020