Asthma Monitor AMOS app

GUDID 04057155000603

Accessory to ERT's Asthma Monitor device for professional users

eResearchTechnology GmbH

Peak flow meter, electronic
Primary Device ID04057155000603
NIH Device Record Key121eb1f2-ea8e-4fe3-a6cc-bb95f84c645a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAsthma Monitor AMOS app
Version Model Number2.x
Company DUNS341625331
Company NameeResearchTechnology GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone1800 7049698
EmailCustomerCare@ert.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com
Phone+1 908 5952020
EmailCustomerCare@clario.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104057155000603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSpirometer, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-12
Device Publish Date2019-11-04

Devices Manufactured by eResearchTechnology GmbH

04057155000580 - SpiroSphere2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
04057155000597 - SpiroSphere2024-07-30 Diagnostic device for ECG measurement and data collection
04057155000665 - SpiroSphere2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
04057155000672 - SpiroSphere2024-07-30 Diagnostic device for ECG measurement and data collection
04057155000689 - SpiroSphere2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
04057155000696 - SpiroSphere2024-07-30 Diagnostic device for ECG measurement and data collection
04057155000795 - iSpiro Ultrasonic Sensor2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters.
04057155000818 - SpiroWay2024-07-30 Mouthpiece, accessory to spirometer

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.