Identity
- Trade Name
- Cardea SOLO FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- Cardea SOLO PC Software - ECG analysis software (D300) FDA UDI
- Model / Reference
- D300 FDA UDI
- Description
- Cardea SOLO PC Software - ECG analysis software (D300) FDA UDI
Identifiers
- Catalog Number
- D300 FDA UDI
- Primary DI / UDI-DI
- 00857553006139 FDA UDI
- FDA Product Code
- DSH FDA UDIDQK FDA UDI
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 FDA UDI870.1425 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic ambulatory recorder
Cardea SOLO by Cardiac Insight, Inc. — 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 Insight, Inc.
Sources (1)
- FDA UDI 7c482d6a-f2d6-4cf8-a6b4-66e3996618ff 34 fields · synced Jun 6, 2026