For use with Macroduct® Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.

For use with Macroduct® Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
Macroduct® Supply Kit, Qty 6 - SS-032

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 Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 03661540302152

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