Identity
- Trade Name
- LightStrike+ FDA UDI
- Generic Name
- Ultraviolet device microbial reduction unit FDA UDI
- Device Name
- Whole Room Microbial Reduction Device FDA UDI
- Model / Reference
- MXSUV1-FT FDA UDI
- Description
- Whole Room Microbial Reduction Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814122020163 FDA UDI
- 510(k) Number
- DEN230007 FDA UDI
- FDA Product Code
- QXJ FDA UDI
- GMDN Term
- Ultraviolet device microbial reduction unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6510 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
No
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
MR Unsafe FDA UDI
Category: Ultraviolet device microbial reduction unit
LightStrike+ by Xenex Disinfection Services, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- LightStrike+ — Xenex Disinfection Services, Inc. · Class II
Cleared under the same submission
DEN230007 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xenex Disinfection Services, Inc.
Sources (1)
- FDA UDI 03f509ed-a6d9-4493-8d92-d7d56a618307 34 fields · synced Jun 6, 2026