AccessGUDID - DEVICE: LightStrike+ (00814122020170)

GUDID

Device Identifier (DI) Information

Brand Name: LightStrike+
Version or Model: MXSUV1-SL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xenex Disinfection Services Inc.

Primary DI Number: 00814122020170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039302870 *Terms of Use

Device Description: Whole Room Microbial Reduction Device

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65824	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QXJ	Whole Room Microbial Reduction Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN230007	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 413c0dd1-4824-48c4-a503-ae8a6f0096b2
Public Version Date: November 14, 2023
Public Version Number: 1
DI Record Publish Date: November 06, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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