Signa Electrode Gel, 2 oz V93-0026-1

GUDID 00817980020863

Signa Electrode Gel, 2 oz

VASOMEDICAL, INC.

Electrode conductive medium Electrode conductive medium

• Primary Device ID: 00817980020863
• NIH Device Record Key: a403f030-e4c3-4252-bb6c-103cee6fb4c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signa Electrode Gel, 2 oz
• Version Model Number: Model Lumenair
• Catalog Number: V93-0026-1
• Company DUNS: 197210248
• Company Name: VASOMEDICAL, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(516)508-5818
• Email: eohara@vasomedical.com
• Phone: +1(516)508-5818
• Email: eohara@vasomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817980020863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033617

FDA Product Code

• DRN: Device, counter-pulsating, external

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2016-11-29

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