tremoflo C2 Device - clearflo

FDA UDI

Class II (US FDA UDI)

by Thorasys Thoracic Medical Systems Inc

Identity

Trade Name: tremoflo C2 Device - clearflo FDA UDI
Generic Name: Pulmonary function analysis system, adult FDA UDI
Device Name: The tremoflo C2 Device - clearflo is the device associated with the tremoflo C2 Airwave Oscillometry System and Accessories. This tremoflo C2 device is intended for use with clearflo filters. This device is part of the tremoflo C2 Airwave Oscillometry System. Refer to UDI 07540261020360 (Packaging DI) for more details. FDA UDI
Model / Reference: 101711 FDA UDI
Description: The tremoflo C2 Device - clearflo is the device associated with the tremoflo C2 Airwave Oscillometry System and Accessories. This tremoflo C2 device is intended for use with clearflo filters. This device is part of the tremoflo C2 Airwave Oscillometry System. Refer to UDI 07540261020360 (Packaging DI) for more details. FDA UDI

Identifiers

Primary DI / UDI-DI: 07540261017117 FDA UDI
FDA Product Code: PNV FDA UDI
GMDN Term: Pulmonary function analysis system, adult FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1840 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Category: Pulmonary function analysis system, adult

tremoflo C2 Device - clearflo by Thorasys Thoracic Medical Systems Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Thorasys Thoracic Medical Systems Inc

Sources (1)

FDA UDI 86d23ac1-d0be-46ff-a1f2-42c139c9dd0c 33 fields · synced Jun 6, 2026