tremoflo C-100 Airwave Oscillometry - Support Arm

GUDID 07540261019234

Optional support arm accessory for the tremoflo C-100 system

Thorasys Thoracic Medical Systems Inc

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• Primary Device ID: 07540261019234
• NIH Device Record Key: 425784bd-b71c-42d0-9922-59c34b0b43aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: tremoflo C-100 Airwave Oscillometry - Support Arm
• Version Model Number: 101923
• 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: 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: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com
• Phone: 5143848555
• Email: techsupport@thorasys.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540261019234 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-11
• Device Publish Date: 2021-11-03

Devices Manufactured by Thorasys Thoracic Medical Systems Inc

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• 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: 2021-11-11Optional support arm accessory for the tremoflo C-100 system
• 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.