Nanoduct Neonatal Sweat Analysis System

GUDID 03661540303418

The Nanoduct Neonatal Sweat Analysis System is intended for laboratory use by qualified personnel to provide laboratory confirmation of a clinical diagnosis of cystic fibrosis.

ELITECHGROUP INC.

Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser

• Primary Device ID: 03661540303418
• NIH Device Record Key: 853c9eea-c9fc-48ed-bdd8-5b000ffb5fd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nanoduct Neonatal Sweat Analysis System
• Version Model Number: Nanoduct Sys 1030
• Company DUNS: 052423787
• Company Name: ELITECHGROUP INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]
GS1	03661540303418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031
• Premarket Notification: K010031

FDA Product Code

• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses
• KTB: Device, Iontophoresis, Specific Uses

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-22
• Device Publish Date: 2016-09-24

Devices Manufactured by ELITECHGROUP INC.

• 03661540302022 - Nanoduct® Electrode Cable Set Assembly: 2021-03-02 For use with Nanoduct Neonatal Sweat Analysis System to induce sweat for diagnosis of Cystic Fibrosis.
• 03661540300011 - 12-slide vented carousel for Aerospray®: 2021-03-01 A 12-slide vented carousel to be used with Aerospray® stainer/cytocentrifuges to facilitate the staining of biological samples.
• 03661540300028 - 30-slide vented carousel for Aerospray®: 2021-03-01 A 30-slide vented carousel to be used with Aerospray® stainer/cytocentrifuges to facilitate the staining of biological samples.
• 03661540300196 - OSMOCOLL® HNL osmolality Controls, 6x1mL: 2021-03-01 Osmocoll HNL Osmolality Controls are for use as controls for osmolality determination by a vapor pressure osmometer.
• 03661540301124 - Nanoduct® Calibration Standard Plate: 2021-03-01 For use with Nanoduct Neonatal Sweat Analysis System to calibrate the conductivity measurement of sweat for diagnosis of Cystic
• 03661540301179 - Cytopro® Rotor: 2021-03-01 The Cytopro Cytocentrifuge rotor is an in vitro diagnostic medical device for fixing biological cell suspensions on glass micros
• 03661540301483 - OPTIMOLE™ Osmolality Standard, 100 mmol/kg, 60x.4mL: 2021-03-01 ELITechGroup's Opti-Mole solution is for calibration of the Vapro Vapor Pressure Osmometer.
• 03661540301490 - OPTIMOLE™ Osmolality Standard, 290 mmol/kg, 60x.4mL: 2021-03-01 ELITechGroup's Opti-Mole solution is for calibration of the Vapro Vapor Pressure Osmometer.