AccessGUDID - DEVICE: Vista Clean Multi-Purpose Solution (00351801021030)

GUDID

Device Identifier (DI) Information

Brand Name: Vista Clean Multi-Purpose Solution
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AH-3665-00000
Company Name: Nomax, Inc.

Primary DI Number: 00351801021030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103220273 *Terms of Use

Device Description: Vista Clean multi-purpose contact lens solution cleans, rinses, disinfects, stores, and conditions contact lenses. Vista Clean is compatible for use with any lens type including RGP lenses, scleral lenses, hybrid lenses, and soft lenses including silicone hydrogel.

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?
48074	Multi-purpose soft/rigid contact lens solution	A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting soft contact lenses and rigid gas permeable (RGP)/hard contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused.	Active	false
48075	Multi-purpose rigid contact lens solution	A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting rigid gas permeable (RGP) and hard contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPN	Accessories, Soft Lens Products

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: c0ca6e0e-b6a7-4528-985a-a18c5f80dc94
Public Version Date: November 11, 2024
Public Version Number: 2
DI Record Publish Date: May 06, 2024