CARESCAPE ONE 2087075-300

GUDID 00195278288639

CARESCAPE ONE MBZ323 ATO MODEL

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: 00195278288639
• NIH Device Record Key: ffba618d-4b4c-4f9d-8c65-be7f54bf9507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESCAPE ONE
• Version Model Number: MBZ323
• Catalog Number: 2087075-300
• Company DUNS: 006580799
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• 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: 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 108 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278288639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213234

FDA Product Code

• DQK: Computer, diagnostic, programmable
• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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: 2022-05-23
• Device Publish Date: 2022-05-13

On-Brand Devices [CARESCAPE ONE]

• 00840682125901: MBZ101
• 00195278288639: CARESCAPE ONE MBZ323 ATO MODEL