Identity
- Trade Name
- CorVitals FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- Wearable Biosensor - ECG Remote Monitoring Biosensor Patch FDA UDI
- Model / Reference
- CV1253 FDA UDI
- Description
- Wearable Biosensor - ECG Remote Monitoring Biosensor Patch FDA UDI
Identifiers
- Catalog Number
- CV1253_US FDA UDI
- Primary DI / UDI-DI
- B353CV12531 FDA UDI
- FDA Product Code
- DRG FDA UDIMWJ FDA UDIMHX FDA UDI
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 FDA UDI870.2800 FDA UDI870.1025 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
CorVitals by LifeSignals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- LifeSignals, Inc.
Sources (1)
- FDA UDI 71a73454-7c62-4615-8c45-9e69e0e8c0d5 37 fields · synced Jun 8, 2026