EasyOne Pro 3000-1

GUDID 07640142190349

NDD Medizintechnik AG

Pulmonary function analysis system, adult

• Primary Device ID: 07640142190349
• NIH Device Record Key: 36a952fb-d7b2-45ee-b0e1-183c27b6d2b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyOne Pro
• Version Model Number: 3000-1
• Catalog Number: 3000-1
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640142190349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091428

FDA Product Code

• BTY: Calculator, Predicted Values, Pulmonary Function

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

Devices Manufactured by NDD Medizintechnik AG

• 07640142190677 - spirette m: 2023-07-03
• 07640142190479 - Spiro-SP TrueFlow Sensor: 2023-07-03
• 07640142190646 - spirette FA Pro/LAB: 2023-07-03
• 07640142190486 - spirette: 2023-06-30
• 07640142190516 - EasyOne FlowTube: 2023-06-30
• 07640142190462 - EasyOne FlowTube: 2023-06-30
• 07640142190561 - Filter Adapter SP: 2023-06-30
• 07640142190578 - Filter Adapter FT: 2023-06-30