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


Product Overview

For use with Macroduct Sweat Collection System to attach electrodes and collectors used to induce and collect sweat for diagnosis of Cystic Fibrosis.
Macroduct® Collection Strap, Medium, Qty 1 - SS-256


Device Description

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.


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: 03661540302787

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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