NxGen Pocket Spirometer

GUDID 00198715872873

NxGen Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out tests. NxGen Pocket Spirometer is intended to be used by patients above 5 years of age to perform basic lung function tests under the instruction of a physician or practitioner licensed by law to measure the health of the lung. Pocket Spirometer is intended to be used under Home Healthcare environment.

SAFEY MEDICAL DEVICES PRIVATE LIMITED

Diagnostic spirometer, professional

• Primary Device ID: 00198715872873
• NIH Device Record Key: 5e028e59-5191-4653-8ca3-914c2fe4b1f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NxGen Pocket Spirometer
• Version Model Number: 165221
• Company DUNS: 878291677
• Company Name: SAFEY MEDICAL DEVICES PRIVATE LIMITED
• 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: 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: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com
• Phone: +919830455253
• Email: info@safeymedicaldevices.com

Device Dimensions

• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram
• Weight: 300 Gram

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 100 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00198715872873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201002

FDA Product Code

• BZG: Spirometer, Diagnostic

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: 2025-02-04
• Device Publish Date: 2025-01-27

On-Brand Devices [NxGen Pocket Spirometer]

• 00198715872873: NxGen Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out
• 00860013746414: NxGen Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out