Macroduct Advanced Sweat Collection System

GUDID 03661540300400

The Macroduct Advanced Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

ELITECHGROUP INC.

Sweat-induction iontophoresis system

• Primary Device ID: 03661540300400
• NIH Device Record Key: 0931b7c0-059d-4967-b9ab-f180df2e3bef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Macroduct Advanced Sweat Collection System
• Version Model Number: Model 3710-Sys
• 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: true
• Manufacturing Date: true
• 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	03661540300400 [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: 2025-03-07
• Device Publish Date: 2025-02-27

On-Brand Devices [Macroduct Advanced Sweat Collection System]

• 03661540304347: The Macroduct System is intended for clinical laboratory use by qualified personnel for stimulat
• 03661540300400: The Macroduct Advanced Sweat Collection System is intended only for clinical laboratory use by q