Icare HOME tonometer

GUDID 06430033850237

ICARE FINLAND OY

Ophthalmic tonometer, battery-operated

• Primary Device ID: 06430033850237
• NIH Device Record Key: 3e434fad-1f7f-4ede-ab86-8d42b4807c2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icare HOME tonometer
• Version Model Number: TA022
• Company DUNS: 651755092
• Company Name: ICARE FINLAND OY
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430033850237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163343

FDA Product Code

• HKX: Tonometer, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-24

On-Brand Devices [Icare HOME tonometer]

• 06430033850237: TA022
• 06430033851074: TA022