vMap Control Unit

GUDID 00860007954177

Vektor Medical, Inc.

Cardiac mapping system computer

• Primary Device ID: 00860007954177
• NIH Device Record Key: b0d0ed54-004a-4a53-b599-acb3154fc1a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: vMap Control Unit
• Version Model Number: VMCU1
• 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: true
• 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	00860007954177 [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: 2021-12-22
• Device Publish Date: 2021-12-13

On-Brand Devices [vMap Control Unit]

• 00860007954177: VMCU1
• 00860007954122: VMCU2