EchoGo

GUDID 05060634690041

ULTROMICS LIMITED

Radiology DICOM image processing application software

• Primary Device ID: 05060634690041
• NIH Device Record Key: 0306de0d-2983-4670-9636-3f2231d1a18d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoGo
• Version Model Number: Heart Failure 1.0
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060634690041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222463

FDA Product Code

• QUO: Adjunctive Heart Failure Status Indicator

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: 2023-02-23
• Device Publish Date: 2023-02-15

On-Brand Devices [EchoGo]

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