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PT1 Low Gain/Hi Pressure Transducer Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0580
Identity
- Trade Name
- PT1 Low Gain/Hi Pressure Transducer Kit EUDAMEDBRAEBON PT1 Low Gain/Hi Pressure Transducer Kit FDA UDI
- Generic Name
- Air/gas pressure transducer FDA UDI
- Device Name
- Pressure Transducer Kit EUDAMEDUltima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains 1 Ultima Pressure Sensor; 1 Connector Cable; 3 Micro Cannulae; 2 Oral + Nasal Cannulae. FDA UDI
- Model / Reference
- 0580 EUDAMEDFDA UDI
- Description
- Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains 1 Ultima Pressure Sensor; 1 Connector Cable; 3 Micro Cannulae; 2 Oral + Nasal Cannulae. FDA UDI
Identifiers
- Catalog Number
- 0580 FDA UDI
- Primary DI / UDI-DI
- B14005800 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140PressureKit43 EUDAMED
- 510(k) Number
- K984431 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Air/gas pressure transducer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Medical Purpose
- Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
PT1 Low Gain/Hi Pressure Transducer Kit 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 | ++B140PressureKit43 | 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-PR-000013743
Sources (2)
- EUDAMED 62d90c93-d052-4650-a676-533349655809 61 fields · synced May 31, 2026
- FDA UDI e0d84928-790f-4676-a1b2-a8ff24d72553 37 fields · synced May 29, 2026