ERT PT

GUDID 04057155000955

Pneumotachograph tube, accessory, single-patient use

eResearchTechnology GmbH

Diagnostic spirometer, professional

• Primary Device ID: 04057155000955
• NIH Device Record Key: 7ada5038-3231-4da2-a08f-0ac9b94c4dba
• 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@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	04057155000948 [Primary]
GS1	04057155000955 [Package]; Contains: 04057155000948; Package: box [10 Units]; In Commercial Distribution
GS1	04057155000962 [Package]; Contains: 04057155000948; 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: 2025-08-19
• Device Publish Date: 2025-08-11

On-Brand Devices [ERT PT]

• 04057155000436: Pneumotachograph tube, accessory, single-patient use
• 04057155000955: Pneumotachograph tube, accessory, single-patient use