Patient Gateway Gateway SM-X205 GSM

GUDID 05060488680311

SM-X205 - 10.5 Screen - GSM PSE Patient Gateway (tablet computer) for use with PSE system (Patient Status Engine).

ISANSYS LIFECARE LIMITED

Physiological measuring device wireless data capture/transfer unit

• Primary Device ID: 05060488680311
• NIH Device Record Key: 1890d395-2762-433a-85cb-e5b293b436d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Gateway
• Version Model Number: SM-X205 - 10.5 Screen - GSM
• Catalog Number: Gateway SM-X205 GSM
• 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: 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	05060488680311 [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: 2024-04-05
• Device Publish Date: 2024-03-28

Devices Manufactured by ISANSYS LIFECARE LIMITED

• 05060488680014 - Isansys: 2024-05-06 Continuous Clinical Thermometer
• 05060488680021 - Isansys: 2024-05-06 Continuous Clinical Thermometer
• 05060488680038 - Isansys: 2024-05-06 Continuous Clinical Thermometer
• 05060488680045 - Isansys: 2024-05-06 Continuous Clinical Thermometer
• 05060488680052 - Isansys: 2024-05-06 Continuous Clinical Thermometer
• 05060488680069 - Isansys: 2024-05-06 Continuous Clinical Thermometer
• 05060488680144 - Isansys: 2024-05-03 Continuous Cardiac Sensor
• 05060488680151 - Isansys: 2024-05-03 Continuous Cardiac Sensor