Icare CLINIC

GUDID 06430033850961

Icare CLINIC

ICARE FINLAND OY

Medical equipment clinical data interfacing software

• Primary Device ID: 06430033850961
• NIH Device Record Key: a1c5641a-4642-4d99-affd-941621b262ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icare CLINIC
• Version Model Number: TS02
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	06430033850961 [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: 2020-02-13
• Device Publish Date: 2020-02-05

Devices Manufactured by ICARE FINLAND OY

• 06430033851098 - iCare PATIENT2: 2024-05-01 iCare PATIENT2 (iOS version)
• 06430033851104 - iCare PATIENT2: 2024-05-01 iCare PATIENT2 (Android version)
• 06430033851463 - iCare IC200: 2023-06-28 iCare IC200 (with Quick Measure feature)
• 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