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BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 3
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 3 FDA UDI
- Generic Name
- Pneumograph FDA UDI
- Device Name
- PVDF Respiratory effort sensor is intended for use during sleep disorder studies as a qualitative measure of respiratory effort for recording onto a data acquisition system. The sensor uses PVDF (piezo-electric) technology and plugs directly into the electrode headbox. FDA UDI
- Model / Reference
- 0528A FDA UDI
- Description
- PVDF Respiratory effort sensor is intended for use during sleep disorder studies as a qualitative measure of respiratory effort for recording onto a data acquisition system. The sensor uses PVDF (piezo-electric) technology and plugs directly into the electrode headbox. FDA UDI
Identifiers
- Catalog Number
- 0528A FDA UDI
- Primary DI / UDI-DI
- B1400528A0 FDA UDI
- 510(k) Number
- K982216 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Pneumograph 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pneumograph
BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 3 by Braebon Medical Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
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 8489be3b-efaf-4753-9ff3-2b0744d8f168 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026