AccessGUDID - DEVICE: HarmonyAIR (00724995170462)

GUDID

Device Identifier (DI) Information

Brand Name: HarmonyAIR
Version or Model: G-Series Suspension
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LK00012
Company Name: STERIS CORPORATION

Primary DI Number: 00724995170462
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The Dual Spindle Light Head 1750mm Single Flat Panel Monitor 1600mm G-Series 11008905 is used with the HarmonyAIR G-Series Suspension System.

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQO	TABLE, OPERATING-ROOM, AC-POWERED

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: dee15c88-a884-44fd-8b19-85e047ef85aa
Public Version Date: January 27, 2021
Public Version Number: 3
DI Record Publish Date: May 19, 2020