Night Shift

GUDID 30850015266196

Night Shift LE Device Kit - Dutch + French

ADVANCED BRAIN MONITORING, INC.

Behavioural therapy electrical stimulation system

• Primary Device ID: 30850015266196
• NIH Device Record Key: b275c397-72a8-4342-aff6-dbc642b5eecc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Night Shift
• Version Model Number: NS27-1005.LE(DUTFRE)
• Company DUNS: 969842715
• Company Name: ADVANCED BRAIN MONITORING, INC.
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	30850015266196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140190

FDA Product Code

• MYB: Pillow,Cervical(For Mild Sleep Apnea)

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: 2021-05-05
• Device Publish Date: 2021-04-27

On-Brand Devices [Night Shift]

• 00851113007031: Night Shift Device Kit - Refurbished
• 00851113007994: Night Shift Strap Kit
• 00850015266188: Night Shift Chest Belt Kit - Traditional Chinese
• 00850015266171: Night Shift Chest Belt Kit - Swedish
• 00850015266164: Night Shift Chest Belt Kit - Spanish
• 00850015266157: Night Shift Chest Belt Kit - Portuguese
• 00850015266140: Night Shift Chest Belt Kit - Norwegian
• 00850015266133: Night Shift Chest Belt Kit - Italian
• 00850015266126: Night Shift Chest Belt Kit - German
• 00850015266119: Night Shift Chest Belt Kit - French
• 00850015266102: Night Shift Chest Belt Kit - Finnish
• 00850015266096: Night Shift Chest Belt Kit - Dutch
• 00850015266089: Night Shift Chest Belt Kit - Danish
• 00850015266072: Night Shift Chest Belt Kit
• 80850015266191: Night Shift LE Device Kit - Portuguese
• 60850015266197: Night Shift LE Device Kit - Italian
• 50850015266190: Night Shift LE Device Kit - German
• 40850015266193: Night Shift LE Device Kit - French
• 30850015266196: Night Shift LE Device Kit - Dutch + French
• 20850015266199: Night Shift LE Device Kit - Dutch
• 00850015266232: Night Shift LE Device Kit - Traditional Chinese
• 00850015266218: Night Shift LE Device Kit - Spanish
• 00850015266195: Night Shift LE Device Kit
• 00850015266515: Night Shift Chest Belt Extension Kit
• 00850015266508: Night Shift Chest Belt Kit XXL
• 00850015266492: Night Shift Chest Belt Kit Standard
• 10850015266192: Night Shift LE Device Kit - Swiss