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Ultima High-Output PVDF Respiratory Effort Sensor
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0529
Identity
- Trade Name
- Ultima High-Output PVDF Respiratory Effort Sensor EUDAMEDBRAEBON Ultima High-Output PVDF Respiratory Effort Sensor FDA UDI
- Generic Name
- Pneumograph FDA UDI
- Device Name
- Respiratory Effort Sensors EUDAMEDPVDF 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
- 0529 EUDAMEDFDA 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
- 0529 FDA UDI
- Primary DI / UDI-DI
- B14005290 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140EffortFU EUDAMED
- Direct Marketing DI
- B14005290 EUDAMED
- 510(k) Number
- K982216 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Pneumograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Ultima High-Output PVDF Respiratory Effort Sensor by Braebon Medical Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | ++B140EffortFU | 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-MF-000002190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 806bc9fe-3268-4f48-b9a8-f5bafcc2ce2e 61 fields · synced Jul 21, 2026
- FDA UDI 2e0cc413-9aa2-45e0-b5dc-aefd633ccf11 37 fields · synced May 29, 2026