NUVO NANO 855

GUDID 00038214002466

PORTABLE OXYGEN CONCENTRATOR

NIDEK MEDICAL PRODUCTS, INC.

Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator 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

Devices Manufactured by NIDEK MEDICAL PRODUCTS, INC.

• 00038214002732 - Penta Flow Oxygen Flow Splitter: 2023-12-21 The Penta Flow Oxygen Flow Splitter is a device intended to distribute oxygen enriched product gas from a source (preferably a N
• 00038214002466 - NUVO NANO: 2023-06-15PORTABLE OXYGEN CONCENTRATOR
• 00038214002466 - NUVO NANO: 2023-06-15 PORTABLE OXYGEN CONCENTRATOR