Meridian™ Iontophoretic Drug Delivery Electrode

GUDID 00702173151915

WR MEDICAL ELECTRONICS CO INC

Drug-delivery iontophoresis system electrode, active Drug-delivery iontophoresis system electrode, active

• Primary Device ID: 00702173151915
• NIH Device Record Key: fb1629a7-8185-41e6-a1da-82c1be6a1248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meridian™ Iontophoretic Drug Delivery Electrode
• Version Model Number: 5191
• Company DUNS: 006196604
• Company Name: WR MEDICAL ELECTRONICS CO INC
• Device Count: 20
• DM Exempt: true
• 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: true
• 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

Customer Support Contacts

• Phone: 651-604-8400
• Email: info@wrmed.com
• Phone: 651-604-8400
• Email: info@wrmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00702173051918 [Unit of Use]
GS1	00702173151915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000574

FDA Product Code

• EGJ: Device, Iontophoresis, Other Uses

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [Meridian™ Iontophoretic Drug Delivery Electrode]

• 00702173152929: 5292
• 00702173151915: 5191