Identity
- Trade Name
- Norav 1200 Series PC-ECG FDA UDI
- Generic Name
- Electrocardiography monitoring system receiver FDA UDI
- Device Name
- PC-ECG Wireless Receiver Device for Stress-Test ECG. The 1200WR is the Digital RF Receiver unit of the PC-ECG 1200W System. Special edition for GE Health Care. FDA UDI
- Model / Reference
- 1200WR FDA UDI
- Description
- PC-ECG Wireless Receiver Device for Stress-Test ECG. The 1200WR is the Digital RF Receiver unit of the PC-ECG 1200W System. Special edition for GE Health Care. FDA UDI
Identifiers
- Catalog Number
- 1200WR-D-00-07 FDA UDI
- Primary DI / UDI-DI
- 07290110255367 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Electrocardiography monitoring system receiver 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
No
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 monitoring system receiver
Norav 1200 Series PC-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 b4eeb5b6-6e2b-41c7-aaf4-b4200c3f7c5b 35 fields · synced May 31, 2026