Identity
- Trade Name
- MonitorMe FDA UDI
- Generic Name
- Electrocardiography telemetric monitoring system FDA UDI
- Device Name
- Wearable Biosensor - ECG Remote Monitoring Biosensor Patch FDA UDI
- Model / Reference
- MM1250 FDA UDI
- Description
- Wearable Biosensor - ECG Remote Monitoring Biosensor Patch FDA UDI
Identifiers
- Primary DI / UDI-DI
- B353MM12501 FDA UDI
- FDA Product Code
- DRG FDA UDIMWJ FDA UDI
- GMDN Term
- Electrocardiography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 FDA UDI870.2800 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
MonitorMe 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 271417b9-6cc2-42f3-b476-678d9f89346c 36 fields · synced May 30, 2026