Nanoduct® Electrode Strap, Large, Qty 1

GUDID 03661540301995

For use with Neonatal Sweat Analysis System to attach electrodes and sensor cells used to induce and collect sweat for diagnosis of Cystic Fibrosis.

ELITECHGROUP INC.

Sweat-induction iontophoresis device/conductivity analyser

• Primary Device ID: 03661540301995
• NIH Device Record Key: 45d35baa-6ded-4a2e-9a1e-4ccb643c1472
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nanoduct® Electrode Strap, Large, Qty 1
• Version Model Number: RP-356
• Company DUNS: 052423787
• Company Name: ELITECHGROUP 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: 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: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540301995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010031

FDA Product Code

• KTB: Device, Iontophoresis, Specific Uses

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: 2021-03-01
• Device Publish Date: 2021-02-19

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