vMap Control Unit

GUDID 00860007954122

Vektor Medical, Inc.

Cardiac mapping system workstation

• Primary Device ID: 00860007954122
• NIH Device Record Key: c34c617b-fd7c-4e41-8074-831f8e4a088d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: vMap Control Unit
• Version Model Number: VMCU2
• Company DUNS: 096643610
• Company Name: Vektor Medical, Inc.
• 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	00860007954122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211546

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2022-11-23
• Device Publish Date: 2022-11-15

On-Brand Devices [vMap Control Unit]

• 00860007954177: VMCU1
• 00860007954122: VMCU2