Identity
- Trade Name
- BRAEBON Communication Cable for MediByte FDA UDI
- Generic Name
- Medical device USB cable FDA UDI
- Device Name
- Cable for connecting the MediByte to the computer for configuration and data download. FDA UDI
- Model / Reference
- 8889.21 FDA UDI
- Description
- Cable for connecting the MediByte to the computer for configuration and data download. FDA UDI
Identifiers
- Catalog Number
- 8889.21 FDA UDI
- Primary DI / UDI-DI
- B1408889210 FDA UDI
- 510(k) Number
- K061764 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Medical device USB cable 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: Medical device USB cable
BRAEBON Communication Cable for MediByte by Braebon Medical Corp. — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K061764 also covers:
- BRAEBON 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Braebon Medical Corp.
Sources (2)
- FDA UDI 146b6121-1b70-49d5-ac93-9b1ed046184d 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026