AccessGUDID - DEVICE: Visine (00074300012537)

GUDID

Device Identifier (DI) Information

Brand Name: Visine
Version or Model: 00074300012537
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Kenvue Brands LLC

Primary DI Number: 00074300012537
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 118772437 *Terms of Use

Device Description: Lubricating and Rewetting Drops for Contacts

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?
48082	Contact lens wetting solution	An aqueous formulation intended to wet contact lenses. The device is dispensed as droplets typically directly on the eyes while the patient wears the contact lenses; it is available in single- or multiple-dose containers. 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 [?]
K991620	000

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
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b106ff71-ca51-4459-8bbc-6332faa90f76
Public Version Date: November 04, 2024
Public Version Number: 7
DI Record Publish Date: September 05, 2016