Macroduct® Sweat Collection System

GUDID 03661540303388

The Macroduct System is intended for clinical laboratory use by qualified personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

ELITECHGROUP INC.

Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system Sweat-induction iontophoresis system
Primary Device ID03661540303388
NIH Device Record Keyd9daa9e4-664c-41f4-9fd3-32b341c9aecc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMacroduct® Sweat Collection System
Version Model NumberModel 3700
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

Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]
GS103661540303388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
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 Date2021-02-23
Device Publish Date2016-09-24

Devices Manufactured by ELITECHGROUP INC.

03661540300110 - Macroduct® Electrode Cable Assembly2021-02-26 For use with Macroduct Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
03661540300349 - Macroduct® Advanced Strap Set, Qty 182021-02-26 For use with Macroduct Advanced Sweat Collection System to attach electrodes and collectors used to induce and collect sweat for
03661540300356 - Macroduct® Advanced Strap Set, Qty 1802021-02-26 For use with Macroduct Advanced Sweat Collection System to attach electrodes and collectors used to induce and collect sweat for
03661540300363 - Macroduct® Advanced Electrode Cable Assembly2021-02-26 For use with Macroduct Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
03661540300530 - Macroduct® Black Electrode Strap, Qty 12021-02-26 For use with Macroduct Sweat Collection System to attach electrodes and collectors used to induce and collect sweat for diagnosi
03661540300547 - Macroduct® Red Electrode Strap, Qty 12021-02-26 For use with Macroduct Sweat Collection System to attach electrodes and collectors used to induce and collect sweat for diagnosi
03661540302084 - Macroduct® Pilogel Discs2021-02-26 For use with Macroduct® Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
03661540302152 - Macroduct® Supply Kit, Qty 62021-02-26 For use with Macroduct® Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.

Trademark Results [Macroduct]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MACRODUCT
MACRODUCT
74288931 1758172 Live/Registered
ELITECHGROUP INC.
1992-06-26
MACRODUCT
MACRODUCT
73537998 1379034 Dead/Cancelled
WESCOR, INC.
1985-05-16

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