EasyOne Diagnostic Spirometer 2001-1

GUDID 07640142190042

NDD Medizintechnik AG

Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional

• Primary Device ID: 07640142190042
• NIH Device Record Key: d7271449-4dfe-4e3d-9136-b22ddb553992
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyOne Diagnostic Spirometer
• Version Model Number: 2001-1
• Catalog Number: 2001-1
• Company DUNS: 487451916
• Company Name: NDD Medizintechnik AG
• 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: 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: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com
• Phone: (978) 470-0923
• Email: customerservice@nddmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640142190042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993921

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [EasyOne Diagnostic Spirometer]

• 07640142190059: 2001-2
• 07640142190042: 2001-1