SpiroSphere

GUDID 04057155000580

Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG

eResearchTechnology GmbH

Diagnostic spirometer, professional

• Primary Device ID: 04057155000580
• NIH Device Record Key: 0a2103d9-5048-45ff-a6ca-9ad7518f7e91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpiroSphere
• Version Model Number: SpiroSphere ECG
• Company DUNS: 341625331
• Company Name: eResearchTechnology GmbH
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057155000580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223629

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-30
• Device Publish Date: 2024-07-22

On-Brand Devices [SpiroSphere]

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• 04057155000528: Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000375: Spirometer sensor unit to measure inspiratory and expiratory pulmonary function
• 04057155000351: Main Unit of diagnostic spirometer for measurement and data collection of lung function paramete
• 04057155000764: Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000757: Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000726: Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000719: Main Unit of diagnostic spirometer for measurement and data collection of lung function paramete
• 04057155000788: Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000771: Main Unit of diagnostic spirometer for measurement and data collection of lung function paramete
• 04057155000696: Diagnostic device for ECG measurement and data collection
• 04057155000689: Diagnostic spirometer for measurement and data collection of lung function parameters with optio
• 04057155000672: Diagnostic device for ECG measurement and data collection
• 04057155000665: Diagnostic spirometer for measurement and data collection of lung function parameters with optio
• 04057155000597: Diagnostic device for ECG measurement and data collection
• 04057155000580: Diagnostic spirometer for measurement and data collection of lung function parameters with optio
• 04057155000825: Main Unit of diagnostic spirometer for measurement and data collection of lung function paramete