Rotationsflowgeber Set

GUDID 04057155000320

Set of three rotary flow sensors for single-patient use, accessory to Asthma Monitor

eResearchTechnology GmbH

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• Primary Device ID: 04057155000320
• NIH Device Record Key: 4d9a587c-c03e-48df-bf72-217ab15c9b59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotationsflowgeber Set
• Version Model Number: Rotationsflowgeber Set
• 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: true
• Lot Batch: true
• 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: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057155000320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090486

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

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• 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