ZonedIn Vision Contact Lenses 088

GUDID 00810040147111

Daily wear soft contact lens -4.25 power 2 trials

ZONEDIN VISION, LLC

Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable

• Primary Device ID: 00810040147111
• NIH Device Record Key: 5a37be0c-c979-42c8-a91e-23f93c0fb32f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZonedIn Vision Contact Lenses
• Version Model Number: 088
• Catalog Number: 088
• Company DUNS: 117142079
• Company Name: ZONEDIN VISION, LLC
• 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810040147111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083288

FDA Product Code

• LPL: Lenses, soft contact, daily wear

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: 2021-02-01
• Device Publish Date: 2021-01-22

On-Brand Devices [ZonedIn Vision Contact Lenses]

• 00810040147302: Daily wear soft contact lens -12.00 power 2 trials
• 00810040147296: Daily wear soft contact lens -11.50 power 2 trials
• 00810040147289: Daily wear soft contact lens -11.00 power 2 trials
• 00810040147272: Daily wear soft contact lens -10.50 power 2 trials
• 00810040147265: Daily wear soft contact lens -10.00 power 2 trials
• 00810040147258: Daily wear soft contact lens -9.50 power 2 trials
• 00810040147241: Daily wear soft contact lens -9.00 power 2 trials
• 00810040147234: Daily wear soft contact lens -8.50 power 2 trials
• 00810040147227: Daily wear soft contact lens -8.00 power 2 trials
• 00810040147210: Daily wear soft contact lens -7.50 power 2 trials
• 00810040147203: Daily wear soft contact lens -7.00 power 2 trials
• 00810040147197: Daily wear soft contact lens -6.50 power 2 trials
• 00810040147180: Daily wear soft contact lens -6.00 power 2 trials
• 00810040147173: Daily wear soft contact lens -5.75 power 2 trials
• 00810040147166: Daily wear soft contact lens -5.50 power 2 trials
• 00810040147159: Daily wear soft contact lens -5.25 power 2 trials
• 00810040147142: Daily wear soft contact lens -5.00 power 2 trials
• 00810040147135: Daily wear soft contact lens -4.75 power 2 trials
• 00810040147128: Daily wear soft contact lens -4.50 power 2 trials
• 00810040147111: Daily wear soft contact lens -4.25 power 2 trials
• 00810040147104: Daily wear soft contact lens -4.00 power 2 trials
• 00810040147098: Daily wear soft contact lens -3.75 power 2 trials
• 00810040147081: Daily wear soft contact lens -3.50 power 2 trials
• 00810040147074: Daily wear soft contact lens -3.25 power 2 trials
• 00810040147067: Daily wear soft contact lens -3.00 power 2 trials
• 00810040147050: Daily wear soft contact lens -2.75 power 2 trials
• 00810040147043: Daily wear soft contact lens -2.50 power 2 trials
• 00810040147036: Daily wear soft contact lens -2.25 power 2 trials
• 00810040147029: Daily wear soft contact lens -2.00 power 2 trials
• 00810040147012: Daily wear soft contact lens -1.75 power 2 trials
• 00810040147005: Daily wear soft contact lens -1.50 power 2 trials
• 00810040146992: Daily wear soft contact lens -1.25 power 2 trials
• 00810040146985: Daily wear soft contact lens -1.00 power 2 trials
• 00810040146978: Daily wear soft contact lens -0.75 power 2 trials
• 00810040146961: Daily wear soft contact lens -0.50 power 2 trials
• 00810040146954: Daily wear soft contact lens +6.00 power 2 trials
• 00810040146947: Daily wear soft contact lens +5.50 power 2 trials
• 00810040146930: Daily wear soft contact lens +5.00 power 2 trials
• 00810040146923: Daily wear soft contact lens +4.50 power 2 trials
• 00810040146916: Daily wear soft contact lens +4.00 power 2 trials
• 00810040146909: Daily wear soft contact lens +3.75 power 2 trials
• 00810040146893: Daily wear soft contact lens +3.50 power 2 trials
• 00810040146886: Daily wear soft contact lens +3.25 power 2 trials
• 00810040146879: Daily wear soft contact lens +3.00 power 2 trials
• 00810040146862: Daily wear soft contact lens +2.75 power 2 trials
• 00810040146855: Daily wear soft contact lens +2.50 power 2 trials
• 00810040146848: Daily wear soft contact lens +2.25 power 2 trials
• 00810040146831: Daily wear soft contact lens +2.00 power 2 trials
• 00810040146824: Daily wear soft contact lens +1.75 power 2 trials
• 00810040146817: Daily wear soft contact lens +1.50 power 2 trials