Identity
- Trade Name
- ECG FDA UDI
- Generic Name
- Electrocardiography telemetric monitoring system FDA UDI
- Device Name
- The ECG-USB1 device provides a single channel ECG for host systems that require an external unit in order to add ECG\Respiration capabilities in an easy and fast way to their platform. The host owner should write its own software application that communicates with the device via USB port using the Norav USB driver and SDK. FDA UDI
- Model / Reference
- ECGUSB1D-EX-FW11/B FDA UDI
- Description
- The ECG-USB1 device provides a single channel ECG for host systems that require an external unit in order to add ECG\Respiration capabilities in an easy and fast way to their platform. The host owner should write its own software application that communicates with the device via USB port using the Norav USB driver and SDK. FDA UDI
Identifiers
- Catalog Number
- ECG Module FDA UDI
- Primary DI / UDI-DI
- 07290110251062 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Electrocardiography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiography telemetric monitoring system
Ecg by Norav Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Norav Medical Inc.
Sources (1)
- FDA UDI b182dec0-c90c-4841-b0ad-21f3df33c757 35 fields · synced May 31, 2026