AccessGUDID - DEVICE: Harmony iQ (00724995199142)

GUDID

Device Identifier (DI) Information

Brand Name: Harmony iQ
Version or Model: Harmony iQ 3600
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RLQ3600SLC
Company Name: BLACK DIAMOND VIDEO, INC.

Primary DI Number: 00724995199142
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 556373053 *Terms of Use

Device Description: The Surgical Light Control and Surgical Camera Control for the Harmony IQ 3600 Integration Systems promotes efficient and prompt reaction to procedure events.

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?
59047	Operating room audiovisual data/device management system application software	An application software program, routines, and/or algorithms intended to be used in an operating room audiovisual data/device management system to enable the system to function according to its intended purpose. The software typically supports remote control of medical and non-medical devices, data management/documentation, and data communication/transfer within and outside of the operating room (OR) [e.g., teleconferencing, teaching/ telesurgery, networking with hospital systems]; it is not intended for long-term storage of patient demographics. It is typically installed into a dedicated integrated network of computers and peripherals.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTA	Light, surgical, accessories

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: d618ba15-ec49-4ab8-8187-ba34ee6252e8
Public Version Date: June 07, 2024
Public Version Number: 2
DI Record Publish Date: April 23, 2021