NUVO NANO 855

GUDID 00038214002466

PORTABLE OXYGEN CONCENTRATOR

NIDEK MEDICAL PRODUCTS, INC.

Stationary oxygen concentrator

• Primary Device ID: 00038214002466
• NIH Device Record Key: e8262a6b-da70-4710-9642-026d3a5101f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NUVO NANO
• Version Model Number: 855
• Catalog Number: 855
• Company DUNS: 161382940
• Company Name: NIDEK MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com
• Phone: 800-822-9255
• Email: info@nidekmedical.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 64 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00038214002466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192693

FDA Product Code

• CAW: Generator, Oxygen, Portable

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: 2023-06-15
• Device Publish Date: 2023-06-07

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• 00038214002466 - NUVO NANO: 2023-06-15PORTABLE OXYGEN CONCENTRATOR
• 00038214002466 - NUVO NANO: 2023-06-15 PORTABLE OXYGEN CONCENTRATOR