Vivid

GUDID 00840682120128

G E MEDICAL SYSTEMS ISRAEL LTD.

Cardiovascular ultrasound imaging system

• Primary Device ID: 00840682120128
• NIH Device Record Key: 12263d9c-b442-4279-9115-288e3851998e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivid
• Version Model Number: S60
• Company DUNS: 532102365
• Company Name: G E MEDICAL SYSTEMS ISRAEL 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

• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682120128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142323

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: 2016-07-08

On-Brand Devices [Vivid]

• 00840682122771: i-q-S5-S6 BT12 UPG
• 00840682120128: S60
• 00840682105316: S70