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tF C-100 Unit-ClearFlo PFT filter compatible
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 101336
Identity
- Trade Name
- tremoflo C100 Airwave Oscillometry System Unit - ClearFlo PFT filter compatible EUDAMEDtF C-100 Unit-ClearFlo PFT filter compatible FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- tremoflo C100 Airwave Oscillometry System Unit - ClearFlo PFT filter compatible EUDAMEDAirwave Oscillometry System to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Version compatible with ClearFlo PFT filter. Includes power supply, ethernet cable, and user manual. FDA UDI
- Model / Reference
- 101336 EUDAMEDFDA UDI
- Description
- Airwave Oscillometry System to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Version compatible with ClearFlo PFT filter. Includes power supply, ethernet cable, and user manual. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540261013362 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07540261013362 EUDAMED
- 510(k) Number
- K170185 FDA UDI
- FDA Product Code
- PNV FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary function analysis system, adult
tF C-100 Unit-ClearFlo PFT filter compatible by Thorasys Thoracic Medical Systems Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K170185 also covers:
- Assembly of tremoflo US software and digital user manual CD — Thorasys Thoracic Medical Systems Inc
- TremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/L — Thorasys Thoracic Medical Systems Inc
- TremoFlo C-100 Calibrated Reference Load 2 cm H2O.s/L — Thorasys Thoracic Medical Systems Inc
- tF Calibrated Reference Load 15cmH2O (2 Years Edition) — Thorasys Thoracic Medical Systems Inc
- tf C-100 Kit Vitalograph - Clinical Trial Edition (28300) — Thorasys Thoracic Medical Systems Inc
- tf C-100 Kit Vitalograph - Healthcare Edition (28500) — Thorasys Thoracic Medical Systems Inc
- tremoFlo US Software — Thorasys Thoracic Medical Systems Inc
- tremoflo C-100 Airwave Oscillometry - Support Arm — Thorasys Thoracic Medical Systems Inc
- tremoflo C-100 Airwave Oscillometry System & Accesories - ERT US Edition — Thorasys Thoracic Medical Systems Inc
- tremoflo C-100 Airwave Oscillometry System & Accesories - US Edition — Thorasys Thoracic Medical Systems Inc
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI 1c7f35cc-32d9-4fe0-a61b-67f385cc6092 36 fields · synced Jun 18, 2026
- EUDAMED 031a83e2-2ed0-4cdf-b9ba-2ebda5d7fefb 61 fields · synced Jun 18, 2026