Vivid

GUDID 00840682119283

GE Medical Systems (China) Co.,Ltd.

Cardiovascular ultrasound imaging system

• Primary Device ID: 00840682119283
• NIH Device Record Key: 9a8c6943-f07e-4cfd-915e-aa6b210682a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivid
• Version Model Number: iq
• Company DUNS: 654658731
• Company Name: GE Medical Systems (China) Co.,Ltd.
• 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 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682119283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161706

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Vivid]

• 00840682139694: iq v203
• 00840682139199: T8 v203
• 00840682139182: T9 v203
• 00840682119283: iq
• 00840682114554: T8 R1 to R2 UPG
• 00840682103794: T8
• 00195278460639: Vivid T8 T9 v204 v205 to v206 upgrade kit SW only
• 00195278460677: Vivid iq v204 to v206 upgrade kit
• 00195278530981: Vivid iq v203 to v206 upgrade kit
• 00195278488527: Vivid iq V204 to V206 SW only upgrade kit
• 00195278460622: Vivid T8 T9 v204 v205 to v206 upgrade kit
• 00195278422286: T8 v206 console
• 00195278422279: T9 v206 console
• 00195278421388: Vivid iq R6 basic console
• 00195278833570: Vivid T8 T9 v206 to v208 SW only upgrade kit with package
• 00195278797551: Vivid iq V206 to V208 SW only upgrade kit with package
• 00195278797513: Vivid iq V206 to V208 HW + SW upgrade kit with package
• 00195278796462: T8 v208 console
• 00195278796455: T9 v208 console
• 00195278783295: Vivid iq v208 basic console