Sweat-Chek™ Sweat Conductivity Analyzer

GUDID 03661540303395

ELITECHGROUP INC.

Sweat conductivity analyser IVD, semi-automated
Primary Device ID03661540303395
NIH Device Record Key8a4e9d78-ddd1-48fe-9954-227457c893b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSweat-Chek™ Sweat Conductivity Analyzer
Version Model NumberModel 3120
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
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
GS103661540303395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGZElectrode, Ion-Specific, Chloride

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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