Icare PATIENT

GUDID 06430033850985

Icare PATIENT

ICARE FINLAND OY

Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software

• Primary Device ID: 06430033850985
• NIH Device Record Key: 665a5aeb-543a-4def-add0-a6db057afede
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icare PATIENT
• Version Model Number: TS04
• 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	06430033850985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200966

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: 2020-05-19
• Device Publish Date: 2020-05-11

Devices Manufactured by ICARE FINLAND OY

• 06430033851463 - iCare IC200: 2023-06-28 iCare IC200 (with Quick Measure feature)
• 06430033851456 - iCare HOME2: 2022-02-16
• 06430033850985 - Icare PATIENT: 2020-05-19Icare PATIENT
• 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