Identity
- Trade Name
- CloudEKG FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals. Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology. The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving and printing by healthcare professionals. CloudEKG can be 'used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings. All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device. FDA UDI
- Model / Reference
- CloudEKG FDA UDI
- Description
- The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals. Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology. The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving and printing by healthcare professionals. CloudEKG can be 'used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings. All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04650075330081 FDA UDI
- 510(k) Number
- K130878 FDA UDI
- FDA Product Code
- DXH FDA UDI
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2920 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: Electrocardiograph, professional, multichannel
CloudEKG by Neurosoft, Ooo — 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
- Neurosoft, Ooo
Sources (1)
- FDA UDI b6ead905-1926-4578-b039-019231725b2d 35 fields · synced May 29, 2026