Macroduct Advanced Electrode Cable Assembly

Basic Information

• Brand Name: Macroduct Advanced Electrode Cable Assembly
• Primary DI: 03661540300370
• Version / Model: AC-203
• Company Name: ELITECHGROUP INC.
• Labeler DUNS: 052423787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-07
• Public Version: 1
• Public Version Date: 2021-06-15
• Public Version Status: New
• Public Device Record Key: 7ad48b5b-0fc8-4e2f-8f3d-7cc59ee2278e

Device Description

The electrode cable assembly connects to the Macroduct Advanced inducer at the electrode connector on the top panel. Both electrodes, one red for the anode (positive) and one black for the cathode (negative), have a stainless-steel disc as the electrode plate. In the center of each electrode is a pin for detecting the Pilogel disc. The electrodes provide current from the device through the Pilogel discs to the patient skin during iontophoresis.

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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	03661540300370	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180627	000