Identity
- Trade Name
- ECG Check FDA UDI
- Generic Name
- Medical networking interface unit FDA UDI
- Device Name
- The ECG Check is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their EGG data to medical professionals via a communication device to a remote server. Specifically, the EGG Check is indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms: * Skipped Beats * Pounding Heart (Palpitations) * Heart Racing or Irregular Pulse * Lightheadedness or Faintness * History of Arrhythmias Prescription FDA UDI
- Model / Reference
- ECG01-U FDA UDI
- Description
- The ECG Check is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their EGG data to medical professionals via a communication device to a remote server. Specifically, the EGG Check is indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms: * Skipped Beats * Pounding Heart (Palpitations) * Heart Racing or Irregular Pulse * Lightheadedness or Faintness * History of Arrhythmias Prescription FDA UDI
Identifiers
- Catalog Number
- ECG01-Universal FDA UDI
- Primary DI / UDI-DI
- B287ECG01U0 FDA UDI
- 510(k) Number
- K122184 FDA UDI
- FDA Product Code
- DXH FDA UDI
- GMDN Term
- Medical networking interface unit 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
Yes
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: Medical networking interface unit
ECG Check by Cardiac Designs, LLC — 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
- Cardiac Designs, LLC
Sources (1)
- FDA UDI 10d65149-371d-4294-b0fc-bba278c7de92 37 fields · synced Jun 8, 2026