For use with Neonatal Sweat Analysis System to attach electrodes and sensor cells used to induce and collect sweat for diagnosis of Cystic Fibrosis.

For use with Neonatal Sweat Analysis System to attach electrodes and sensor cells used to induce and collect sweat for diagnosis of Cystic Fibrosis.
Nanoduct® Electrode Strap, Small, Qty 1 - RP-354

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).

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: 03661540301971

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