LightStrike+
- Primary DI
- 00814122020163
- Brand
- LightStrike+
- Company
- Xenex Disinfection Services Inc.
- Model
- MXSUV1-FT
- Device description
- Whole Room Microbial Reduction Device
- Published
- 2023-11-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| QXJ | Whole Room Microbial Reduction Device |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QXJ | Whole Room Microbial Reduction Device | General Hospital | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| DEN230007 | 000 | LightStrike+ (MXSUV1-SL and MXSUV1-FT) | Xenex Disinfection Services, Inc. | 2023-09-01 | QXJ |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00814122020163 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00814122020163 | 00814122020163 | 814122020163 | 0814122020163 |
GMDN Terms
| Term | Definition |
|---|
| Ultraviolet device microbial reduction unit | A portable electrically-powered device intended to reduce microbial and organic soil loads on the surface of noninvasive medical equipment, and other non-porous contact surfaces, using ultraviolet C (UVC) light; it is not intended for device disinfection. It includes UVC lights and controls and is intended to be placed in proximity to the devices to be decontaminated. |
Regulatory Flags
- DUNS number
- 039302870
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00814122020170 | LightStrike+ | MXSUV1-SL | | 2023-11-06 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00814122020170 | LightStrike+ | Xenex Disinfection Services Inc. | QXJ | 2023-11-06 |