CARESCAPE Central Station

GUDID 00840682109666

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Patient monitoring system central station monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor

• Primary Device ID: 00840682109666
• NIH Device Record Key: cd4ea8d4-cdf7-4597-a8de-8cb9054876f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESCAPE Central Station
• Version Model Number: V2 Integrated MAI 700
• Company DUNS: 784985108
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1075 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1075 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1075 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1075 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682109666 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162012

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-11

On-Brand Devices [CARESCAPE Central Station]

• 00840682109666: V2 Integrated MAI 700
• 00840682109604: V2 Standard MAS 700