AccessGUDID - DEVICE: Bausch + Lomb (00310119096055)

GUDID

Device Identifier (DI) Information

Brand Name: Bausch + Lomb
Version or Model: 629605
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FCP-4086
Company Name: Bausch & Lomb Incorporated

Primary DI Number: 00310119096055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196603781 *Terms of Use

Device Description: 3.5 FL OZ Conditioning, 1.0 FL OZ Cleaner, Four 0.01 FLOZ Liquid Enzyme, 1 Lens Case

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):	Yes
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?
45088	Contact lens care kit	A collection of devices and supplies used in the general care of reusable contact lenses. This device is typically a container (e.g., a carton, pouch, or bag) containing the necessary materials for disinfecting and wetting the contact lenses and for their storage when not in use (e.g., a sterile cleaning solution and a lens case). Some devices may also include the contact lenses as part of the initial kit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRC	Products, Contact Lens Care, Rigid Gas Permeable

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: 5e11c476-3e3b-40a2-bd59-a7f06e67a00e
Public Version Date: May 15, 2024
Public Version Number: 3
DI Record Publish Date: December 18, 2018