Identity
- Trade Name
- LUX-Dx™ Clinic Assistant app FDA UDI
- Generic Name
- Implantable cardiac device management application software FDA UDI
- Device Name
- LUX-Dx Clinic Assistant app (Mobile application) FDA UDI
- Model / Reference
- 622935-100 FDA UDI
- Description
- LUX-Dx Clinic Assistant app (Mobile application) FDA UDI
Identifiers
- Catalog Number
- 622935-100 FDA UDI
- Primary DI / UDI-DI
- 00802526607615 FDA UDI
- FDA Product Code
- MXD FDA UDI
- GMDN Term
- Implantable cardiac device management application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Implantable cardiac device management application software
LUX-Dx™ Clinic Assistant app by Boston Scientific — 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
- Boston Scientific
Sources (1)
- FDA UDI 162aff39-db50-420d-a0e9-3b610f57c882 34 fields · synced Jun 8, 2026