Identity
- Trade Name
- tremoflo C100 Airwave Oscillometry System - ClearFlo F100 PFT Filter EUDAMEDClearflo PFT Filter in bag FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- tremoflo EUDAMEDClearflo PFT Filter. Used with tremoFlo Airwave Oscillometry System. FDA UDI
- Model / Reference
- 101421 EUDAMEDFDA UDI
- Description
- Clearflo PFT Filter. Used with tremoFlo Airwave Oscillometry System. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540261014215 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540261tremofloC2N6 EUDAMED
- FDA Product Code
- PNV FDA UDI
- EMDN Code
- R0499 RESPIRATORY FILTERS - OTHER EUDAMED
- GMDN Term
- Pulmonary function testing filter/mouthpiece 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Pulmonary function testing filter/mouthpiece
Clearflo PFT Filter in bag by Thorasys Thoracic Medical Systems Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function testing filter/mouthpiece.
- SP-MIX 1 - bombola da 10 L — Air Liquide Italia Gas e Servizi S.r.l. · Class IIa
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Neonatal Flow Sensor — Respironics Novametrix, LLC · Class IIa
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
- Disposable Flow Transducer — Medikro Oy · Class IIa
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thorasys Thoracic Medical Systems Inc
Sources (2)
- FDA UDI 2bdbf1f6-f364-4867-87a6-3e24b60b6fb0 34 fields · synced Jul 15, 2026
- EUDAMED f4c6dc53-8753-4067-9741-4b73cd01bce9 61 fields · synced Jul 15, 2026