Identity
- Trade Name
- X-Series, X8 FDA UDI
- Generic Name
- Medical networking interface unit FDA UDI
- Device Name
- Bluetooth Dongle FDA UDI
- Model / Reference
- 31-1003 FDA UDI
- Description
- Bluetooth Dongle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851113007260 FDA UDI
- FDA Product Code
- GWQ FDA UDIOLV FDA UDIOMC FDA UDI
- GMDN Term
- Medical networking interface unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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
No
FDA UDI
Category: Medical networking interface unit
X-Series, X8 by Advanced Brain Monitoring, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131383 also covers:
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
K152040 also covers:
- Sleep Profiler — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc.
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
- Advanced Brain Monitoring, Inc.
Sources (1)
- FDA UDI 83fed772-bf62-446e-91ed-5671185318e6 34 fields · synced Jun 8, 2026