Venue

GUDID 00840682119825

GE Medical Systems (China) Co.,Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 00840682119825
• NIH Device Record Key: f5b9bd34-aa43-4736-9e28-a2c3454f3795
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venue
• Version Model Number: 40 BT11 to BT12 UPG
• 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

Customer Support Contacts

• Phone: +1(800)437-1171
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682119825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112122

FDA Product Code

• IYN: System, imaging, pulsed doppler, 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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-01

On-Brand Devices [Venue]

• 00840682119849: 40 BT11 to BT12 UPG with KMST
• 00840682119825: 40 BT11 to BT12 UPG
• 00840682114479: 50 R4 to R5 UPG
• 00840682107624: 50