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
Primary Device ID03661540303418
NIH Device Record Key853c9eea-c9fc-48ed-bdd8-5b000ffb5fd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNanoduct Neonatal Sweat Analysis System
Version Model NumberNanoduct Sys 1030
Company DUNS052423787
Company NameELITECHGROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540303418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTBDevice, Iontophoresis, Specific Uses

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-22
Device Publish Date2016-09-24

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