AccessGUDID - DEVICE: Amazon Basic Care (00195515043199)

GUDID

Device Identifier (DI) Information

Brand Name: Amazon Basic Care
Version or Model: B0CJ9SR8QF
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMAZON.COM SERVICES LLC

Primary DI Number: 00195515043199
Issuing Agency: GS1
Commercial Distribution End Date: December 12, 2027
Device Count: 2
Labeler D-U-N-S® Number*: 128990418 *Terms of Use

Device Description: Amazon Basic Care Multi-Purpose Solution Premium Solution 2x12 oz Twin Pack

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):	No
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?
45870	Multi-purpose soft contact lens solution	A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting reusable soft 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
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: af6b08c6-e16c-467e-b053-da29c52d215f
Public Version Date: December 20, 2023
Public Version Number: 1
DI Record Publish Date: December 12, 2023