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Q-Rip To Belt Controller Cable For Alice
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8592A
Identity
- Trade Name
- Q-RIP TO BELT CONTROLLER CABLE FOR ALICE EUDAMEDFDA UDI
- Generic Name
- Pneumograph FDA UDI
- Device Name
- Respiratory Effort Sensors EUDAMEDCable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier. FDA UDI
- Model / Reference
- 8592A EUDAMEDFDA UDI
- Description
- Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier. FDA UDI
Identifiers
- Catalog Number
- 8592A FDA UDI
- Primary DI / UDI-DI
- B1408592A0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140EffortFU EUDAMED
- Direct Marketing DI
- B1408592A0 EUDAMED
- 510(k) Number
- K001743 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES 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
Dimensions & Sizes
- Size
- Length — 48 Inch FDA UDI
Q-Rip To Belt Controller Cable For Alice by Braebon Medical Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 09473722-4714-4e97-a7e4-f8f0750a24e4 61 fields · synced Jun 18, 2026
- FDA UDI 4638df79-30ba-420f-ac05-e69917c71604 38 fields · synced May 30, 2026