Identity
- Trade Name
- BRAEBON Interface Strap FDA UDI
- Generic Name
- Electrode/transducer strap, reusable 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. FDA UDI
- Model / Reference
- 0584 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. FDA UDI
Identifiers
- Catalog Number
- 0584 FDA UDI
- Primary DI / UDI-DI
- B14005840 FDA UDI
- 510(k) Number
- K984431 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Electrode/transducer strap, reusable 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Inch FDA UDI
Category: Air/gas pressure transducerElectrode/transducer strap, reusable
BRAEBON Interface Strap by Braebon Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K984431 also covers:
- 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 579e99d5-961d-4290-b9a0-dd942932842a 37 fields · synced May 30, 2026