EchoGo

GUDID 05060634690010

ULTROMICS LIMITED

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• Primary Device ID: 05060634690010
• NIH Device Record Key: 590a051c-5af8-475b-afd1-1bd592d73f53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoGo
• Version Model Number: Pro
• Company DUNS: 222850684
• Company Name: ULTROMICS LIMITED
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060634690010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201555

FDA Product Code

• POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

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: 2021-02-15
• Device Publish Date: 2021-02-05

On-Brand Devices [EchoGo]

• 05060634690003: Core
• 05060634690010: Pro
• 05060634690027: Core 2.0
• 05060634690041: Heart Failure 1.0