AccessGUDID - DEVICE: Lumin (00860006339906)

GUDID

Device Identifier (DI) Information

Brand Name: Lumin
Version or Model: LM3000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 3B MEDICAL, INC.

Primary DI Number: 00860006339906
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078517316 *Terms of Use

Device Description: Lumin serves as both a general-purpose sanitizing device for personal care items (e.g. cell phone, eyeglasses, keys, etc.) as well as CPAP accessories (e.g. hose, mask, and water chamber. In terms of CPAP sanitizer, there is no requirement for sterility or disinfection for single-patient re-use of CPAP accessories in the home. Most manufacturer instructions require simple cleaning with soap and water. Lumin is intended to be used as an adjunct to following the manufacturer’s instructions for routine cleaning but provides the convenience of bioburden reduction in 5 minutes. Lumin is designed to be used only with the CPAP accessories (i.e. CPAP Mask, hose, and water chamber), and not on the CPAP machine itself.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
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?
65162	Ultraviolet device disinfection chamber	An electrically-powered unit including an ultraviolet radiation light source designed to destroy bacteria and viruses on small medical or non-medical devices (e.g., smartphones, hand-helds, weapons, tools) which are placed within its chamber. It is typically a cupboard-like device with doors and may have shelves inside. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRJ	Disinfectant, Medical Devices

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 90c3109c-bdf2-45e9-9526-43346ee97b52
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: February 01, 2021