Identity
- Trade Name
- myLUX™ Patient Kit with mobile device FDA UDI
- Generic Name
- Implantable cardiac device management application software FDA UDI
- Device Name
- MyLUX(TM) Patient Kit with mobile device FDA UDI
- Model / Reference
- 666259-100 FDA UDI
- Description
- MyLUX(TM) Patient Kit with mobile device FDA UDI
Identifiers
- Catalog Number
- 666259-100 FDA UDI
- Primary DI / UDI-DI
- 00802526607363 FDA UDI
- 510(k) Number
- K193473 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
Yes
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
MR Unsafe FDA UDI
Category: Implantable cardiac device management application software
myLUX™ Patient Kit with mobile device by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K193473 also covers:
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 228d4525-8848-4eba-9b40-d5f9ee900a3f 35 fields · synced May 30, 2026