iCare PATIENT2

GUDID 06430033851098

iCare PATIENT2 (iOS version)

ICARE FINLAND OY

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)