Asthma Monitor AMOS app

GUDID 04057155000603

Accessory to ERT's Asthma Monitor device for professional users

eResearchTechnology GmbH

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• Primary Device ID: 04057155000603
• NIH Device Record Key: 121eb1f2-ea8e-4fe3-a6cc-bb95f84c645a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Asthma Monitor AMOS app
• Version Model Number: 2.x
• 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: false
• Manufacturing Date: false
• 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: 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: +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	04057155000603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183479

FDA Product Code

• BZG: Spirometer, Diagnostic

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: 2019-11-12
• Device Publish Date: 2019-11-04

Devices Manufactured by eResearchTechnology GmbH

• 04057155000771 - SpiroSphere: 2024-03-19 Main Unit of diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000788 - SpiroSphere: 2024-03-19 Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000337 - Rotationsflowgeber: 2021-03-19 Rotary flow sensor for single-patient use, accessory to Asthma Monitor
• 04057155000719 - SpiroSphere: 2021-02-26 Main Unit of diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000726 - SpiroSphere: 2021-02-26 Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000757 - SpiroSphere: 2021-02-26 Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000764 - SpiroSphere: 2021-02-26 Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000566 - MasterScope: 2021-02-22 Spirometer sensor to measure inspiratory and expiratory pulmonary function for connection to software