P-Rohr Set SpiroPro

GUDID 04057155000382

Set of ten Pneumotachograph tubes, single-patient use, accessory to SpiroPro

eResearchTechnology GmbH

Diagnostic spirometer

• Primary Device ID: 04057155000382
• NIH Device Record Key: 8cd4a924-2a28-425c-a55c-970832069aa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P-Rohr Set SpiroPro
• Version Model Number: P-Rohr Set SpiroPro
• 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: +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@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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057155000382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031515

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-29

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• 04057155000665 - SpiroSphere: 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
• 04057155000672 - SpiroSphere: 2024-07-30 Diagnostic device for ECG measurement and data collection
• 04057155000689 - SpiroSphere: 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
• 04057155000696 - SpiroSphere: 2024-07-30 Diagnostic device for ECG measurement and data collection
• 04057155000795 - iSpiro Ultrasonic Sensor: 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters.
• 04057155000818 - SpiroWay: 2024-07-30 Mouthpiece, accessory to spirometer