EchoPAC

GUDID 00840682141697

GE Vingmed Ultrasound AS

Ultrasound imaging system application software

• Primary Device ID: 00840682141697
• NIH Device Record Key: ed6ea896-012a-41ab-b35b-ce312a72cb8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoPAC
• Version Model Number: Plug-in v203
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682141697 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170847

FDA Product Code

• LLZ: System, image processing, radiological

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: 2019-02-22
• Device Publish Date: 2019-01-22

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
• 00195278951717: MD EchoPAC Plug-In v210
• 00195278951700: MD EchoPAC Software Only v210