Isansys Gateway SM-X200 – 10.5 - WiFi

GUDID 05060488680304

Data entry & local display point tablet computer, 10.5 Screen

ISANSYS LIFECARE LIMITED

Physiological measuring device wireless data capture/transfer unit

• Primary Device ID: 05060488680304
• NIH Device Record Key: 14fe8f49-bd44-4c6b-8137-68e6d892cfce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isansys
• Version Model Number: Patient Gateway SM-X200 – 10.5 - WiFi
• Catalog Number: Gateway SM-X200 – 10.5 - WiFi
• Company DUNS: 216707432
• Company Name: ISANSYS LIFECARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	05060488680304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172329

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

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: 2024-05-03
• Device Publish Date: 2024-04-25

On-Brand Devices [Isansys]

• 05060488680304: Data entry & local display point tablet computer, 10.5 Screen
• 05060488680069: Continuous Clinical Thermometer
• 05060488680052: Continuous Clinical Thermometer
• 05060488680045: Continuous Clinical Thermometer
• 05060488680267: Data entry & local display point tablet computer, 10.1 Screen
• 05060488680250: Data entry & local display point tablet computer, 10.1 Screen
• 05060488680205: Data entry & local display point tablet computer, 10.1 Screen
• 05060488680182: Data entry & local display point tablet computer, 10.1 Screen
• 05060488680175: Lifeguard Server - Data Server & remote display
• 05060488680168: Continuous Cardiac Sensor
• 05060488680151: Continuous Cardiac Sensor
• 05060488680144: Continuous Cardiac Sensor
• 05060488680038: Continuous Clinical Thermometer
• 05060488680021: Continuous Clinical Thermometer
• 05060488680014: Continuous Clinical Thermometer