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Vasomedical-Biox™ (2306 12 CH +2 more) - Bluetooth
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Vasomedical-Biox™ Model 2306 12 CH/ABP COMB Recorder w/Bluetooth FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- Model 2306 12 CH/ABP COMB Recorder w/Bluetooth FDA UDI
- Model / Reference
- Model 2306 Kit FDA UDI
- Description
- Model 2306 12 CH/ABP COMB Recorder w/Bluetooth FDA UDI
Identifiers
- Catalog Number
- A10-2306-00 FDA UDI
- Primary DI / UDI-DI
- 00817980020542 FDA UDI
- 510(k) Number
- K111096 FDA UDI
- FDA Product Code
- DSH FDA UDI
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
- Models / Variants
- 2306 12 CH FDA UDIABP COMB Recorder w FDA UDIBluetooth FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiographic ambulatory recorder
Vasomedical-Biox™ (2306 12 CH +2 more) - Bluetooth by Vasomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — 3 models — regulatory data on deviCERTS
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Also classified as Electrocardiographic ambulatory recorder.
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Cleared under the same submission
K111096 also covers:
- Vasomedical-Biox™ 1806 ABP Monitor With Analysis S/W — VASOMEDICAL, INC.
- Vasomedical-Biox™ 1807 ABP Monitor With Analysis S/W w/ Bluetooth — VASOMEDICAL, INC.
- Vasomedical-Biox™ 2302 Combined 12 Channel ECG Holter & ABP Monitor — VASOMEDICAL, INC.
- Vasomedical-Biox™ Model 1805 Ambulatory Blood Pressure Recorder — VASOMEDICAL, INC.
- Vasomedical-Biox™ Model 1806 Ambulatory Blood Pressure Recorder — VASOMEDICAL, INC.
- Vasomedical-Biox™ Model 1807 Ambulatory Blood Pressure Recorder w/Bluetooth — VASOMEDICAL, INC.
- Vasomedical-Biox™ Model 2304 12 CH/ABP COMB Recorder — VASOMEDICAL, 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
- Vasomedical, Inc.
Sources (1)
- FDA UDI 31d2d08c-869c-43f6-aa86-b27d3b5cf859 37 fields · synced May 31, 2026