Electrically Conductive Gel (ECG)

GUDID 00616784123912

Electrically Conductive Gel (ECG), Conductive, Noncorrosive , Salt & Alcohol Free, Water Soluble

DYNAREX CORPORATION

Electrode conductive medium

• Primary Device ID: 00616784123912
• NIH Device Record Key: 0e8d47d2-b7e8-470a-8f30-e5eeff5fc71e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electrically Conductive Gel (ECG)
• Version Model Number: 1239
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: true
• Lot Batch: false
• 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	00616784123912 [Primary]
GS1	00616784123936 [Package]; Package: [72 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962681

FDA Product Code

• GYB: Media, Electroconductive

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: 2021-02-17
• Device Publish Date: 2021-02-09

On-Brand Devices [Electrically Conductive Gel (ECG)]

• 00616784123912: Electrically Conductive Gel (ECG), Conductive, Noncorrosive , Salt & Alcohol Free, Water Soluble
• 00616784124018: Electrically Conductive Gel (ECG), Conductive, Noncorrosive, Salt & Alcohol Free, Water Soluble