Cleaning & Disinfecting Lens Care System

GUDID 00011822545358

RITE AID CORPORATION

Multi-purpose soft/rigid contact lens solution

• Primary Device ID: 00011822545358
• NIH Device Record Key: bd7eae7f-abfe-41e1-9f07-d79a8d23d1a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cleaning & Disinfecting Lens Care System
• Version Model Number: 052
• Company DUNS: 014578892
• Company Name: RITE AID CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00011822545358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010559

FDA Product Code

• LPN: Accessories, Soft Lens Products

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-18
• Device Publish Date: 2019-12-10

On-Brand Devices [Cleaning & Disinfecting Lens Care System]

• 00011822545860: 052
• 00011822545358: 052