- Physicians Office Resource

For use with Nanoduct Neonatal Sweat Analysis System to induce sweat for diagnosis of Cystic Fibrosis.
Nanoduct® Electrode Cable Set Assembly - RP-359

Device Description

A portable, battery-powered electronic device intended to induce sweating by the transdermal introduction of a water-soluble electrolytic substance (i.e., pilocarpine) into the sweat glands using an electric stimulus (iontophoresis), and subsequently measure the electrical conductivity of the sweat using a continuous flow cell; thus providing an indication of the total electrolyte concentration. It typically consists of a portable conductivity analyser that contacts the patient via microelectrodes embedded in a non-conductive sensor held against the stimulated skin. The device is used to help diagnose cystic fibrosis (CF).

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: KTB

Device Name: Device, Iontophoresis, Specific Uses

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: PM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 890.5525

Third Party Flag: Y

Medical Specialty: PM

Device Identifiers

Device Id: 03661540302022

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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