EchoPAC

GUDID 00195278504326

MD EchoPAC Plug-in v206

GE Vingmed Ultrasound AS

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• Primary Device ID: 00195278504326
• NIH Device Record Key: 78bef87e-6a5f-47d5-9270-edd6cc8d8fd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoPAC
• Version Model Number: Plug-in v206
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278504326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220940

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2022-08-31
• Device Publish Date: 2022-08-23

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