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BRAEBON PT2 Dual Differntial Airflow Pressure Kit for Alice
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BRAEBON PT2 Dual Differntial Airflow Pressure Kit for Alice FDA UDI
- Generic Name
- Air/gas pressure transducer FDA UDI
- Device Name
- 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 Dual Pressure Sensor; 2 Interface cables; 1 Pressure Sensor Interface; 2 Micro Cannulae; 2 Oral + Nasal Cannulae. FDA UDI
- Model / Reference
- 0580A FDA 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 Dual Pressure Sensor; 2 Interface cables; 1 Pressure Sensor Interface; 2 Micro Cannulae; 2 Oral + Nasal Cannulae. FDA UDI
Identifiers
- Catalog Number
- 0580A FDA UDI
- Primary DI / UDI-DI
- B1400580A0 FDA UDI
- 510(k) Number
- K984431 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Air/gas pressure transducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA 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
BRAEBON PT2 Dual Differntial Airflow Pressure Kit for Alice by Braebon Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K984431 also covers:
- BRAEBON Interface Strap — Braebon Medical Corp.
- BRAEBON PT Lite Low Gain Pressure Transducer Kit — Braebon Medical Corp.
- BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice — Braebon Medical Corp.
- BRAEBON PT2 Dual Differntial Airflow Pressure Kit — Braebon Medical Corp.
- BRAEBON Pressure Sensor-NOX — Braebon Medical Corp.
- BRAEBON Ultima Esophageal Pressure Transducer — Braebon Medical Corp.
- BRAEBON Ultima Pressure Sensor — Braebon Medical Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Braebon Medical Corp.
Sources (1)
- FDA UDI e608084e-5342-44a3-a882-0b31abde91d7 38 fields · synced Jun 1, 2026