← Back to catalogue
tremoflo C-100 Airwave Oscillometry System & Accesories - ERT US Edition
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1025853
Identity
- Trade Name
- tremoflo C-100 Airwave Oscillometry System & Accessories - ERT US Edition EUDAMEDtremoflo C-100 Airwave Oscillometry System & Accesories - ERT US Edition FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- tremoflo C-100 Airwave Oscillometry System & Accessories - ERT US Edition EUDAMEDAirwave Oscillometry System (ERT US Edition) compatible with ClearFlo PFT filter including power supply, ethernet cable, user manual, two power cords, test load adapter and packaged with accessories: tremoFlo unit (DI 07540261013362), test load (DI 07540261009860). System used to measure respiratory system impedance using the Forced Oscillation Technique (FOT). FDA UDI
- Model / Reference
- 1025853 EUDAMED102585 FDA UDI
- Description
- Airwave Oscillometry System (ERT US Edition) compatible with ClearFlo PFT filter including power supply, ethernet cable, user manual, two power cords, test load adapter and packaged with accessories: tremoFlo unit (DI 07540261013362), test load (DI 07540261009860). System used to measure respiratory system impedance using the Forced Oscillation Technique (FOT). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540261025853 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07540261025853 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
Yes
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
No
FDA UDI
Category: Pulmonary function analysis system, adult
tremoflo C-100 Airwave Oscillometry System & Accesories - ERT US Edition by Thorasys Thoracic Medical Systems Inc — Class II — MDD, FDA UDI — listed in FDA…
Similar devices
Also classified as Pulmonary function analysis system, adult.
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- VISCOFLU — PHARMA LINE Srl · Class IIb
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
- Vyaire — Jaeger Medical GmbH · Class II
- AEROCHAMBER PLUS FLOW-VU — TRUDELL MEDICAL INTERNATIONAL · Class I
- Shape II System Refurbished — Shape Medical Systems, Inc. · Class II
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
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 C-100 Unit-ClearFlo PFT filter compatible — 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 - 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thorasys Thoracic Medical Systems Inc
Sources (2)
- FDA UDI 76b7caaf-2bd3-42c5-8977-e3ba9f0709e0 36 fields · synced Jul 20, 2026
- EUDAMED 0e12d68d-15b0-4389-8630-99fe11286a68 61 fields · synced Jul 20, 2026