ERT PT

GUDID 04057155000436

Pneumotachograph tube, accessory, single-patient use

eResearchTechnology GmbH

Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional

• Primary Device ID: 04057155000436
• NIH Device Record Key: f9399e8d-13c6-49b1-94ad-8a6244c9def4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERT PT
• Version Model Number: ERT PT
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• 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	04057155000412 [Primary]
GS1	04057155000429 [Package]; Contains: 04057155000412; Package: box [10 Units]; In Commercial Distribution
GS1	04057155000436 [Package]; Contains: 04057155000412; Package: box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173937

FDA Product Code

• BTY: Calculator, Predicted Values, Pulmonary Function

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: 2019-03-11
• Device Publish Date: 2019-02-25

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