Assembly of tremoflo US software and digital user

GUDID 07540261016400

CD with US version of tremoflo Oscillometry System Software (DI 07540261013454) and User Manual.

Thorasys Thoracic Medical Systems Inc

Pulmonary function analysis system, adult

• Primary Device ID: 07540261016400
• NIH Device Record Key: 194d6474-5ea9-4533-b608-f3dfb6ba7523
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assembly of tremoflo US software and digital user
• Version Model Number: 101640
• Company DUNS: 257777701
• Company Name: Thorasys Thoracic Medical Systems Inc
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: 5143848555
• Email: techsupport@thorasys.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540261016400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170185

FDA Product Code

• PNV: Impedance Measuring Device Utilizing Oscillation Techniques

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: 2018-01-16

Devices Manufactured by Thorasys Thoracic Medical Systems Inc

• 07540261016646 - tf C2 Sensor Module - clearflo: 2025-08-14 The tremoflo C2 Sensor Module - clearflo is the sensor module for use with tremoflo C2 device model 101711.
• 07540261017117 - tremoflo C2 Device - clearflo: 2025-08-14 The tremoflo C2 Device - clearflo is the device associated with the tremoflo C2 Airwave Oscillometry System and Accessories. Thi
• 07540261019470 - tremoflo C2 Reference Test Load: 2025-08-14 The tremoflo C2 Reference Test Load (model 101947) is used for field calibration of the tremoflo C2.
• 07540261020360 - tremoflo C2 Airwave Oscillometry System and Accessories: 2025-08-14 The tremoflo C2 Airwave Oscillometry System and Accessories features the following: a tremoflo C2 device (device model varies de
• 07540261022333 - tF C2 Sensor Module Labelled - Eco BVF: 2025-08-14 The tremoflo C2 Sensor Module - Eco BVF is the sensor module for use with tremoflo C2 device model 102237.
• 07540261022371 - tremoflo C2 Device - Yellow - VTG 28554: 2025-08-14 The tremoflo C2 Device - Yellow - VTG 28554 is the device associated with the tremoflo C2 Airwave Oscillometry System and Access
• 07540261017612 - tf C-100 Kit Vitalograph - Clinical Trial Edition (28300): 2024-09-30 The tremoflo C-100 Airwave Oscillometry System and Accessories - Vitalograph Clinical Trial Edition is compatible with Vitalogra
• 07540261020698 - tF Calibrated Reference Load 15cmH2O (2 Years Edition): 2024-09-30 2 year valid Reference Load (15 cm H2O.s/L) to verify tremoflo Airwave Oscillometry System calibration.