tF C-100 Unit-ClearFlo PFT filter compatible

GUDID 07540261013362

Airwave Oscillometry System to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Version compatible with ClearFlo PF

Thorasys Thoracic Medical Systems Inc

Pulmonary function analysis system, adult

• Primary Device ID: 07540261013362
• NIH Device Record Key: 1c7f35cc-32d9-4fe0-a61b-67f385cc6092
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: tF C-100 Unit-ClearFlo PFT filter compatible
• Version Model Number: 101336
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540261013362 [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: 2018-01-12

Devices Manufactured by Thorasys Thoracic Medical Systems Inc

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• 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.