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BRAEBON PT2 Dual Differntial Airflow Pressure Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- BRAEBON PT2 Dual Differntial Airflow Pressure Kit 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 Micro Nasal Cannulae; 2 Oral + Nasal Cannulae. FDA UDI
- Model / Reference
- 0580D 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 Micro Nasal Cannulae; 2 Oral + Nasal Cannulae. FDA UDI
Identifiers
- Catalog Number
- 0580D FDA UDI
- Primary DI / UDI-DI
- B1400580D0 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
- 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
Category: Air/gas pressure transducer
BRAEBON PT2 Dual Differntial Airflow Pressure Kit by Braebon Medical Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Air/gas pressure transducer.
- Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I
- ATMOS Air-Charged Pressure Sensor — MEDKONSULT medical technology s.r.o. · Class II
- MedPak — LIFEPORT, LLC. · Class II
- Air-Charged Reusable Cable — Laborie Medical Technologies Canada ULC · Class II
- MEDPAK — LIFEPORT, LLC. · Class I
- ATMOS Air-Charged Pressure Sensor — MEDKONSULT medical technology s.r.o. · Class II
- Air-Charged Reusable Cable — Laborie Medical Technologies Canada ULC · Class II
- Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I
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 Pressure Sensor-NOX — Braebon Medical Corp.
- BRAEBON Ultima Esophageal Pressure Transducer — Braebon Medical Corp.
- BRAEBON Ultima Pressure Sensor — Braebon Medical Corp.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Braebon Medical Corp.
Sources (2)
- FDA UDI 51a75a12-ad04-4c25-bd19-316d5d92de10 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026