AccessGUDID - DEVICE: PuriLens Plus Disinfecting System (00830002000063)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00830002000063
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: Starter Kit contents: Electrical voltage adapter, PuriLens Unit, removable cleaning/disinfecting chamber, two 4-oz. (120-mL) bottles PuriLens Plus Preservative-free Saline, instruction booklet.

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:	Yes
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?
60838	Contact lens rinsing solution	A sterile solution intended to be used to rinse debris or chemical agents from contact lenses (soft or rigid) prior to insertion; it may be intended to be used during storage or heat disinfection of contact lenses, or to dilute other contact lens solutions (e.g., contact lens protein-removal solution). It is an aqueous saline solution containing preservatives [e.g., edetate disodium (EDTA)] and buffering agents; it does not contain disinfecting, protein-removal, cleaning, or wetting agents. After application, this device cannot be reused.	Active	false
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
LPN	Accessories, Soft Lens Products
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: Yes
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: f603c2f5-66c7-4782-971c-966346e7816b
Public Version Date: June 16, 2023
Public Version Number: 2
DI Record Publish Date: September 24, 2021