Unetixs Vascular 11949-0000-01

GUDID B4371194904

The MultiLab Series 2 LHS is intended for use as a non-invasive diagnostic device by trained medical personnel following physician orders. This device is intended for the detection of obstruction to blood flow in human arteries and veins as an aid for the diagnosis of disease in the peripheral vascular system.

UNETIXS VASCULAR, INC.

Limb plethysmograph

• Primary Device ID: B4371194904
• NIH Device Record Key: 16669290-21fc-4998-a822-b6f0624ac416
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unetixs Vascular
• Version Model Number: Multilab Series 2 LHS
• Catalog Number: 11949-0000-01
• Company DUNS: 625463146
• Company Name: UNETIXS VASCULAR, 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: false
• 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
HIBCC	B4371194904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904392

FDA Product Code

• JAF: Monitor, Ultrasonic, Nonfetal

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: 2023-03-07
• Device Publish Date: 2023-02-27

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• B4371199606: The MultiLab Series 2 2CP is intended for use as a non-invasive diagnostic device by trained med
• B4371198605: The MultiLab is intended for use as a non-invasive diagnostic device by trained medical personne
• B4371194904: The MultiLab Series 2 LHS is intended for use as a non-invasive diagnostic device by trained med