Identity
- Trade Name
- Heart Smart FDA UDI
- Generic Name
- Telemetric electrocardiographic ambulatory recorder FDA UDI
- Device Name
- ECG Recorder FDA UDI
- Model / Reference
- Sirona FDA UDI
- Description
- ECG Recorder FDA UDI
Identifiers
- Catalog Number
- RX93030-007 FDA UDI
- Primary DI / UDI-DI
- 00851074007323 FDA UDI
- 510(k) Number
- K112601 FDA UDI
- FDA Product Code
- MWJ FDA UDI
- GMDN Term
- Telemetric electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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
Yes
FDA UDI
Category: Telemetric electrocardiographic ambulatory recorder
Heart Smart by Datrix Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Datrix Llc
Sources (1)
- FDA UDI a9d3fb4d-2729-4275-ac9d-1bf3576b828b 36 fields · synced May 30, 2026