NxGen Peak Flow Meter

GUDID 00198715485813

NxGen Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects.

SAFEY MEDICAL DEVICES PRIVATE LIMITED

Expiratory peak flow meter, digital

• Primary Device ID: 00198715485813
• NIH Device Record Key: 99be5486-3a37-4db1-9fb2-7d043d3f10ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NxGen Peak Flow Meter
• Version Model Number: 165253
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• Email: info@safeymedicaldevices.com
• Phone: (983)0455253
• 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 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
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00198715485813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200832

FDA Product Code

• BZH: Meter, Peak Flow, Spirometry

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

Devices Manufactured by SAFEY MEDICAL DEVICES PRIVATE LIMITED

• 00198715485813 - NxGen Peak Flow Meter: 2025-02-04NxGen Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects.
• 00198715485813 - NxGen Peak Flow Meter: 2025-02-04 NxGen Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in hom
• 00198715872873 - NxGen Pocket Spirometer: 2025-02-04 NxGen Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out tests. NxGen Pocket Spirometer
• 08908014292003 - Safey Pocket Spirometer: 2022-02-14 Safey Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out tests. Safey Pocket Spirometer
• 08908014292010 - Safey Peak Flow Meter: 2022-02-14 Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in hom