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cTherm Cannula Thermistor for MediByte
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8514Model 0510
Identity
- Trade Name
- cTherm Cannula Thermistor for MediByte EUDAMEDBRAEBON cTherm Cannula Thermistor for MediByte FDA UDI
- Generic Name
- General-purpose patient temperature probe, reusable FDA UDI
- Device Name
- Ultima Airflow Sensor EUDAMEDCannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for use with MediByte. FDA UDI
- Model / Reference
- 0510 EUDAMED8514 EUDAMEDFDA UDI
- Description
- Cannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for use with MediByte. FDA UDI
Identifiers
- Catalog Number
- 8514 FDA UDI
- Primary DI / UDI-DI
- B14085140 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140AirflowRF EUDAMED
- Direct Marketing DI
- B14085140 EUDAMED
- 510(k) Number
- K981445 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose patient temperature probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
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
cTherm Cannula Thermistor for MediByte by Braebon Medical Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B140AirflowRF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-MF-000002190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED e43dd912-e1eb-434b-83ae-d9b0745f8de3 61 fields · synced Jul 13, 2026
- FDA UDI a3351bed-4d16-4e6a-8687-4b1bf5963186 37 fields · synced May 27, 2026