iCare PATIENT2

GUDID 06430033851098

iCare PATIENT2 (iOS version)

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

• Primary Device ID: 06430033851098
• NIH Device Record Key: f76dda2b-c606-4947-9273-b65d4c10d863
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCare PATIENT2
• Version Model Number: TS05
• 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: true
• 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	06430033851098 [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: 2024-05-01
• Device Publish Date: 2024-04-23

On-Brand Devices [iCare PATIENT2]

• 06430033851104: iCare PATIENT2 (Android version)
• 06430033851098: iCare PATIENT2 (iOS version)