iCare IC200

GUDID 06430033851463

iCare IC200 (with Quick Measure feature)

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: 06430033851463
• NIH Device Record Key: 98be5e28-ecb5-4404-a9ce-bddaaf5b918c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCare IC200
• Version Model Number: TA031
• 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	06430033851463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220852

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: 2023-06-28
• Device Publish Date: 2023-06-20

On-Brand Devices [iCare IC200]

• 06430033851036: The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intrao
• 06430033851463: iCare IC200 (with Quick Measure feature)