OXYSEPT

Basic Information

• Brand Name: OXYSEPT
• Primary DI: 00827444000140
• Version / Model: 93002
• Catalog Number: 93002
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Labeler DUNS: 103021940
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-02-26
• Public Version Status: Update
• Public Device Record Key: 55bc3dd5-a5a0-4e77-afbf-bdc3264b876e

Device Description

OXYSEPT (ULTRACARE) 12OZ + 36 TABLETS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPN	Accessories, Soft Lens Products	Ophthalmic	886.5928	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45599	Contact lens protein-removal solution	A formulation of proteolytic enzymes, that may or may not be dissolved in cleaning (and possibly disinfecting) contact lens solution, used to remove debris and protein deposits from reusable contact lenses, or to remove protein deposits only. The lenses are typically soaked for a period in the solution and then rinsed in fresh contact lens cleaning solution for the removal of any residual material. Protein build-up on contact lenses often occurs from tear secretion. After application, this device cannot be reused.	No	Active
45869	Soft contact lens cleaning solution	An aqueous formulation containing appropriate agents for loosening debris from reusable soft 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	00827444000140	GS1
Package	10827444000147	GS1	Box	6	In Commercial Distribution
Package	30827444000141	GS1	Case	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]