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BRAEBON Ultima Body Position Sensor for Alice 5
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- BRAEBON Ultima Body Position Sensor for Alice 5 FDA UDI
- Generic Name
- Patient positioning sensor FDA UDI
- Device Name
- Five-position sensor to accurately record body position during sleep studies. FDA UDI
- Model / Reference
- 0533 FDA UDI
- Description
- Five-position sensor to accurately record body position during sleep studies. FDA UDI
Identifiers
- Catalog Number
- 0533 FDA UDI
- Primary DI / UDI-DI
- B14005330 FDA UDI
- 510(k) Number
- K981969 FDA UDI
- FDA Product Code
- LEL FDA UDI
- GMDN Term
- Patient positioning sensor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Commercial Distribution
- Not 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
BRAEBON Ultima Body Position Sensor for Alice 5 by Braebon Medical Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 6ad200da-c635-425e-a5bc-e19fed349aee 38 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026