Vivid

GUDID 00195278422279

T9 v206 console

GE Medical Systems (China) Co.,Ltd.

Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system

• Primary Device ID: 00195278422279
• NIH Device Record Key: acfca3e8-10ae-4884-bef4-9efb83178801
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivid
• Version Model Number: T9 v206
• Company DUNS: 654658731
• Company Name: GE Medical Systems (China) Co.,Ltd.
• 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

• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 3 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278422279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221147

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

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: 2022-09-07
• Device Publish Date: 2022-08-30

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