Identity
- Trade Name
- Ultima Airflow Sensor EUDAMEDBRAEBON Ultima Airflow Sensor FDA UDI
- Generic Name
- General-purpose patient temperature probe, reusable FDA UDI
- Device Name
- Ultima Airflow Sensor EUDAMEDThermistor airflow sensor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording onto a data acquisition system. FDA UDI
- Model / Reference
- 0510 EUDAMEDFDA UDI
- Description
- Thermistor airflow sensor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording onto a data acquisition system. FDA UDI
Identifiers
- Catalog Number
- 0510 FDA UDI
- Primary DI / UDI-DI
- B14005100 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140AirflowRF EUDAMED
- Direct Marketing DI
- B14005100 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
- France 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
Ultima Airflow Sensor by Braebon Medical Corporation — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981445 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++B140AirflowRF | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-MF-000002190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED f791b915-0be5-4eed-b76b-22c0c598463c 61 fields · synced Oct 6, 2026
- FDA UDI a22c3f73-acdf-4c19-bc86-0ed004fc375f 37 fields · synced May 30, 2026
- FDA 510(k) K981445 1 fields · synced May 18, 2026