Identity
- Trade Name
- BRAEBON MediByte FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a warranty replacement unit. FDA UDI
- Model / Reference
- MP8-W FDA UDI
- Description
- The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a warranty replacement unit. FDA UDI
Identifiers
- Catalog Number
- MP8-W FDA UDI
- Primary DI / UDI-DI
- B140MP8W0 FDA UDI
- 510(k) Number
- K061764 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Polysomnograph 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: Polysomnograph
BRAEBON MediByte 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
K061764 also covers:
- BRAEBON Communication Cable for MediByte — Braebon Medical Corp.
- BRAEBON MediByte — Braebon Medical Corp.
- BRAEBON MediByte — Braebon Medical Corp.
- BRAEBON MediByte — Braebon Medical Corp.
- BRAEBON MediByte Jr. — Braebon Medical Corp.
- BRAEBON MediByte Jr. — Braebon Medical Corp.
- BRAEBON MediByte Jr. — Braebon Medical Corp.
- BRAEBON MediByte Jr. Kit — Braebon Medical Corp.
- BRAEBON MediOX — Braebon Medical Corp.
- BRAEBON Short Leadwire Kit for MediByte — Braebon Medical Corp.
- BRAEBON SpO2 Cable for MediByte, Medium — Braebon Medical Corp.
- BRAEBON SpO2 Cable for MediByte, Small Soft Shell — 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 55c057f6-adce-449d-9929-b1cbe96f687c 37 fields · synced Jun 8, 2026