AccessGUDID - DEVICE: PuriLens Plus Disinfecting System 110V Adapter (00830002000070)

GUDID

Device Identifier (DI) Information

Brand Name: PuriLens Plus Disinfecting System 110V Adapter
Version or Model: MS0610/H
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: LIFESTYLE CO INC, THE

Primary DI Number: 00830002000070
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 946065000 *Terms of Use

Device Description: Replacement 110V Adapter packaged in plastic zip-lock bag.

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":	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?
45872	Contact lens agitation cleaning system, mechanical	An assembly of devices used to clean and disinfect contact lenses through automated or manual mechanical agitation (e.g., spinning, shaking, wiping). It may consist of a reservoir to hold contact lens solution and the lenses, a base, a cap, and additional components, however other configurations are possible. Some assemblies may include an ultraviolet (UV) radiation source.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYL	Accessories, Solution, Ultrasonic Cleaners For Lenses

FDA Premarket Submission

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

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: 3a7bdd4a-386a-4b86-b569-fb6f9627b240
Public Version Date: June 16, 2023
Public Version Number: 2
DI Record Publish Date: September 24, 2021