Identity
- Trade Name
- KardiaBand System FDA UDI
- Generic Name
- Electrocardiograph, professional, single-channel FDA UDI
- Device Name
- The Kardia Band System is a trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. FDA UDI
- Model / Reference
- AC-011 FDA UDI
- Description
- The Kardia Band System is a trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B210AC0110 FDA UDI
- 510(k) Number
- K171816 FDA UDI
- FDA Product Code
- DPS FDA UDIDXH FDA UDI
- GMDN Term
- Electrocardiograph, professional, single-channel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 FDA UDI870.2920 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
KardiaBand System by AliveCor — 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
- AliveCor
Sources (1)
- FDA UDI 3dbc3f2a-54b1-4dc6-8c0b-69c90da38300 37 fields · synced Jun 1, 2026