iCare HOME2

GUDID 06430033851456

ICARE FINLAND OY

Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated

• Primary Device ID: 06430033851456
• NIH Device Record Key: 3441235d-f124-4569-823c-cb9efe114d04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCare HOME2
• Version Model Number: TA023
• 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	06430033851456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211355

FDA Product Code

• HKY: Tonometer, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-16
• Device Publish Date: 2022-02-08

Devices Manufactured by ICARE FINLAND OY

• 06430033851463 - iCare IC200: 2023-06-28 iCare IC200 (with Quick Measure feature)
• 06430033851456 - iCare HOME2: 2022-02-16
• 06430033851456 - iCare HOME2: 2022-02-16
• 06430033850985 - Icare PATIENT: 2020-05-19 Icare PATIENT
• 06430033851074 - Icare HOME tonometer: 2020-05-19
• 06430033850947 - Probes for HOME: 2020-05-12 Sales package 20pcs of TP022 probes
• 16430033850623 - Probes for HOME: 2020-05-12 Sales package 50pcs
• 06430033850626 - Probes for HOME: 2020-05-12 Single unit blister package
• 06430033850961 - Icare CLINIC: 2020-02-13 Icare CLINIC