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

• 07540261020797 - tremoflo C-100 Kit - Ganshorn SpiroDef Mouthpiece Variant Edition: 2024-04-22 The tremoflo C-100 Airwave Oscillometry System and Accessories - Ganshorn SpiroDef Mouthpiece Variant Kit is compatible with the
• 07540261010590 - TremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/L: 2021-11-11 Reference load (15 cm cm H2O.s/L) to verify TremoFlo Oscillometry System calibration.
• 07540261019234 - tremoflo C-100 Airwave Oscillometry - Support Arm: 2021-11-11 Optional support arm accessory for the tremoflo C-100 system
• 07540261025853 - tremoflo C-100 Airwave Oscillometry System & Acces: 2018-08-20 Airwave Oscillometry System (ERT US Edition) compatible with ClearFlo PFT filter including power supply, ethernet cable, user ma
• 07540261009860 - TremoFlo C-100 Calibrated Reference Load 2 cm H2O.: 2018-07-06 Reference load to verify TremoFlo Oscillometry System calibration.
• 07540261013362 - tF C-100 Unit-ClearFlo PFT filter compatible: 2018-07-06 Airwave Oscillometry System to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Version compa
• 07540261013454 - tremoFlo US Software: 2018-07-06 tremoFlo Airwave Oscillometry System software component (US Version). System to measure respiratory system impedance using the
• 07540261014215 - Clearflo PFT Filter in bag: 2018-07-06 Clearflo PFT Filter. Used with tremoFlo Airwave Oscillometry System.