tf C-100 Kit Vitalograph - Healthcare Edition (28500)

GUDID 07540261021817

The tremoflo C-100 Airwave Oscillometry System & Accessories - Vitalograph US Healthcare Edition is compatible with Vitalograph's Eco BVF with Bit Lip Filter (28553).

Thorasys Thoracic Medical Systems Inc

Pulmonary function analysis system, adult

• Primary Device ID: 07540261021817
• NIH Device Record Key: 3dea7778-5315-4a39-bf87-e46ab0ecce27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: tf C-100 Kit Vitalograph - Healthcare Edition (28500)
• Version Model Number: 102181
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540261021817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170185

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: 2024-09-30
• Device Publish Date: 2024-09-20

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.