Macroduct® Advanced Strap Set, Qty 18

GUDID 03661540300349

For use with Macroduct Advanced Sweat Collection System to attach electrodes and collectors used to induce and collect sweat for diagnosis of Cystic Fibrosis.

ELITECHGROUP INC.

Sweat-induction iontophoresis system

• Primary Device ID: 03661540300349
• NIH Device Record Key: 5fc7d879-330e-44b5-a83f-d448093a7fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Macroduct® Advanced Strap Set, Qty 18
• Version Model Number: SS-269
• 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) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540300349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180627

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: 2021-02-26
• Device Publish Date: 2021-02-18

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