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® Electrode Cable Assembly - RP-383

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

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: 03661540300110

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