AccessGUDID - DEVICE: HarmonyAIR (00724995165031)

GUDID

Device Identifier (DI) Information

Brand Name: HarmonyAIR
Version or Model: Utility Hub - LMC5210M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LMC5210M
Company Name: STERIS CORPORATION

Primary DI Number: 00724995165031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The HarmonyAIR Utility Hub All Power Data Gas 39.4-inch Arm with Mount is a customizable unit for routing electricity, video and data, and a limited number of medical gasses to the operative site while reducing the number of wall plates needed and the routing of cords and wires on the floor.

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):	Yes
Over the Counter (OTC):	No
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?
35630	General utility supply system, ceiling-mounted	An assembly of devices that form a permanent ceiling-mounted system that provides easy access to utilities/amenities (e.g., electricity, gas, or gas scavenging). It is used in the operating room (OR), examination rooms, the recovery department, the intensive care unit (ICU), and accident and emergency (A&E) rooms. It typically consists of a ceiling fixture support, equipped with moveable arms (often multi-jointed) and a pendant head. It can include an equipment carrier for mounting other medical devices.	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: ddefd4bc-f24f-4311-a3f5-93b8ecf04f59
Public Version Date: April 19, 2021
Public Version Number: 1
DI Record Publish Date: April 09, 2021