Icare ic200

GUDID 06430033851036

The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic200 tonometer measures the IOP by utilizing the rebound method. The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye. Icare ic200 allows IOP measurement of patients in all positions between sitting and supine positions. IOP measurement result can be transferred to printer or to a PC via Bluetooth connection.

ICARE FINLAND OY

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• Primary Device ID: 06430033851036
• NIH Device Record Key: 385b0c2f-6aef-4469-9264-e6d57d5075ac
• 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: false
• 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	06430033851036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190316

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: 2020-01-27
• Device Publish Date: 2020-01-17

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)