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

FDA UDI

by Thorasys Thoracic Medical Systems Inc

Identity

Trade Name: tf C-100 Kit Vitalograph - Healthcare Edition (28500) FDA UDI
Generic Name: Pulmonary function analysis system, adult FDA UDI
Device Name: The tremoflo C-100 Airwave Oscillometry System & Accessories - Vitalograph US Healthcare Edition is compatible with Vitalograph's Eco BVF with Bit Lip Filter (28553). FDA UDI
Model / Reference: 102181 FDA UDI
Description: The tremoflo C-100 Airwave Oscillometry System & Accessories - Vitalograph US Healthcare Edition is compatible with Vitalograph's Eco BVF with Bit Lip Filter (28553). FDA UDI

Identifiers

Primary DI / UDI-DI: 07540261021817 FDA UDI
510(k) Number: K170185 FDA UDI
GMDN Term: Pulmonary function analysis system, adult FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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Combination Product

FDA UDI

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

tf C-100 Kit Vitalograph - Healthcare Edition (28500) by Thorasys Thoracic Medical Systems Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K170185 also covers:

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	N/A	Pending data

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Manufacturer

Manufacturer: Thorasys Thoracic Medical Systems Inc

Sources (1)

FDA UDI 3dea7778-5315-4a39-bf87-e46ab0ecce27 34 fields · synced May 30, 2026