Macroduct® Sweat Collection System

Basic Information

• Brand Name: Macroduct® Sweat Collection System
• Primary DI: 03661540303388
• Version / Model: Model 3700
• Catalog Number: Model 3700-SYS
• Company Name: ELITECHGROUP INC.
• Labeler DUNS: 052423787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-03-11
• Public Version Status: Update
• Public Device Record Key: d9daa9e4-664c-41f4-9fd3-32b341c9aecc

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTB	Device, Iontophoresis, Specific Uses	Physical Medicine	890.5525	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15128	Sweat-induction iontophoresis system	An assembly of devices designed to induce sweating by the transdermal introduction of water-soluble electrolytic substances, typically containing pilocarpine, into the sweat glands using an electric stimulus (iontophoresis). It typically consists of a generator that supplies variable low-voltage electricity via two connected electrodes. After stimulus application a sweat sample is collected from the area where the positive electrode was located. The chloride and/or sodium concentration of this sweat sample is then analysed, primarily to help diagnose cystic fibrosis (CF). Devices associated with sweat collection/containment may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03661540303388	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K853973	000