Zenlens Patient Kit

Basic Information

• Brand Name: Zenlens Patient Kit
• Primary DI: 00196527447258
• Version / Model: ZPK8
• Catalog Number: ZPK8
• Company Name: Bausch & Lomb Incorporated
• Labeler DUNS: 196603781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-17
• Public Version: 1
• Public Version Date: 2025-06-25
• Public Version Status: New
• Public Device Record Key: 91b9daa9-eab3-4566-be88-a6ad99a67eef

Device Description

Patient Kit including ScleralFil (3x 10ml), DMV inserter/remover, Boston SIMPLUS Multi-Action Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	886.5918	2
KYE	Inserter/Remover Contact Lens	Ophthalmic	886.5420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42810	Rigid contact lens inserter/remover	A device designed to insert and remove hard and semi-rigid contact lenses from the eye. It typically consists of a small, hand-held device that has a handle and a concave cup-like distal end; some devices include a vented handle that provides manually-adjustable suction for lens removal. The device is used to avoid hard and semi-rigid lens contamination and to facilitate lens removal and insertion typically by users with low dexterity, long nails, or rough fingers; it is also used by contact lens wearers in dirty environments. This is a reusable device.	No	Active
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.	No	Active
45866	Rigid contact lens cleaning solution	An aqueous formulation containing appropriate agents for loosening debris from rigid gas permeable (RGP) or hard contact lenses, often with a gentle rubbing of the lenses. This GMDN code does not include solutions that remove protein or disinfect. The device is used mainly for daily care of the lens. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00196527447258	GS1