SpiroSphere

GUDID 04057155000764

Diagnostic spirometer for measurement and data collection of lung function parameters

eResearchTechnology GmbH

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Primary Device ID04057155000764
NIH Device Record Key03fceb9c-861b-4f74-a2ab-08568cf6f71c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpiroSphere
Version Model NumberSpiroSphere Standard
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 7049698
EmailCustomerCare@ert.com
Phone+1800 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
GS104057155000764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTYCalculator, Predicted Values, Pulmonary Function

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-26
Device Publish Date2021-02-18

On-Brand Devices [SpiroSphere]

04057155000542Diagnostic spirometer for measurement and data collection of lung function parameters
04057155000535Diagnostic spirometer for measurement and data collection of lung function parameters
04057155000528Diagnostic spirometer for measurement and data collection of lung function parameters
04057155000375Spirometer sensor unit to measure inspiratory and expiratory pulmonary function
04057155000351Main Unit of diagnostic spirometer for measurement and data collection of lung function paramete
04057155000764Diagnostic spirometer for measurement and data collection of lung function parameters
04057155000757Diagnostic spirometer for measurement and data collection of lung function parameters
04057155000726Diagnostic spirometer for measurement and data collection of lung function parameters
04057155000719Main Unit of diagnostic spirometer for measurement and data collection of lung function paramete
04057155000788Diagnostic spirometer for measurement and data collection of lung function parameters
04057155000771Main Unit of diagnostic spirometer for measurement and data collection of lung function paramete

Trademark Results [SpiroSphere]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPIROSPHERE
SPIROSPHERE
79126731 4513062 Live/Registered
eResearchTechnology GmbH
2012-12-21

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