SpiroSphere

GUDID 04057155000719

Main Unit of diagnostic spirometer for measurement and data collection of lung function parameters

eResearchTechnology GmbH

Diagnostic spirometer

• Primary Device ID: 04057155000719
• NIH Device Record Key: 33d245ef-2f3b-48a3-84ed-0c4f35c61243
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpiroSphere
• Version Model Number: SpiroSphere Main Unit
• 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: false
• 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: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057155000719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173937

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: 2021-02-26
• Device Publish Date: 2021-02-18

On-Brand Devices [SpiroSphere]

• 04057155000542: Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000535: Diagnostic spirometer for measurement and data collection of lung function parameters
• 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