Rotationsflowgeber

GUDID 04057155000337

Rotary flow sensor for single-patient use, accessory to Asthma Monitor

eResearchTechnology GmbH

Expiratory peak flow meter, digital
Primary Device ID04057155000337
NIH Device Record Keyd8c7fce8-711c-497d-a065-b713697fa420
Commercial Distribution StatusIn Commercial Distribution
Brand NameRotationsflowgeber
Version Model NumberRotationsflowgeber
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 Usetrue
Lot Batchtrue
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

Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@ert.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com
Phone+4993057209891
EmailCustomerCare@clario.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104057155000337 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-03-19
Device Publish Date2019-07-22

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.