MOC

GUDID 07290019141006

MRI multi-channel optical communication system

OPTOACOUSTICS LTD

Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system

• Primary Device ID: 07290019141006
• NIH Device Record Key: 59857ee2-1efe-4899-ad61-81caeaa5e6b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOC
• Version Model Number: IMROC-IR with OptoACTIVE
• Company DUNS: 514834824
• Company Name: OPTOACOUSTICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com
• Phone: 1-866-867-5029
• Email: info@optoacoustics.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 103 KiloPascal
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019141006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121239

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-26
• Device Publish Date: 2024-01-18