SCENTIFIC Respiratory Biofeedback 03U111000

GUDID 07290019255055

SCENTIFIC Respiratory Biofeedback is an instrument that provides a visual signal corresponding to the status of respiration, guiding the user to nasal breathing.

APPSCENT MEDICAL LTD

Psychophysiological biofeedback system

• Primary Device ID: 07290019255055
• NIH Device Record Key: 0b1c092d-ec22-4c6d-a167-df61f96aeefd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCENTIFIC Respiratory Biofeedback
• Version Model Number: 2
• Catalog Number: 03U111000
• Company DUNS: 532387650
• Company Name: APPSCENT MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 77 KiloPascal and 101 KiloPascal
• Storage Environment Atmospheric Pressure: Between 77 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 77 KiloPascal and 101 KiloPascal
• Storage Environment Atmospheric Pressure: Between 77 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019255055 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

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: 2026-02-24
• Device Publish Date: 2026-02-16

Devices Manufactured by APPSCENT MEDICAL LTD

• 07290019255055 - SCENTIFIC Respiratory Biofeedback: 2026-02-24SCENTIFIC Respiratory Biofeedback is an instrument that provides a visual signal corresponding to the status of respiration, guiding the user to nasal breathing.
• 07290019255055 - SCENTIFIC Respiratory Biofeedback: 2026-02-24 SCENTIFIC Respiratory Biofeedback is an instrument that provides a visual signal corresponding to the status of respiration, gui
• 07290019255109 - Scentific Test Kit: 2026-02-24 The Scentific test device is used to determine whether an olfactory loss is present. The device includes scents that are present