EchoPAC

GUDID 00840682104333

GE Vingmed Ultrasound AS

Ultrasound imaging system application software

• Primary Device ID: 00840682104333
• NIH Device Record Key: 79d4c746-0e87-4f84-ac8c-98ad94820310
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoPAC
• Version Model Number: Plug-in v201
• Company DUNS: 518870571
• Company Name: GE Vingmed Ultrasound AS
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682104333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150085

FDA Product Code

• LLZ: System, image processing, radiological

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: 2016-08-01

On-Brand Devices [EchoPAC]

• 00840682141703: Software Only v203
• 00840682141697: Plug-in v203
• 00840682123518: Plug-in v202
• 00840682123501: Software Only v202
• 00840682121095: Software Only v113
• 00840682104333: Plug-in v201
• 00840682103961: Software Only v201
• 00840682146876: Plug-in v204
• 00840682146883: Software Only v204
• 00195278504326: MD EchoPAC Plug-in v206
• 00195278504302: MD EchoPAC Software Only v206