FDA.reportPublic FDA data

Macroduct® Advanced 3710 Sweat Collection System

Primary DI
03661540304347
Brand
Macroduct® Advanced 3710 Sweat Collection System
Company
ELITECHGROUP INC.
Model
Model 3710
Catalog number
Model 3710
Device description
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.
Published
2018-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTBDevice, Iontophoresis, Specific Uses

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTBDevice, Iontophoresis, Specific UsesPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180627000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180627000Macroduct Advanced Model 3710Elitechgroup, Inc.2018-07-27KTB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540304347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540304347036615403043473661540304347

GMDN Terms#

Term, Definition table
TermDefinition
Sweat-induction iontophoresis systemAn assembly of devices designed to induce sweating by the transdermal introduction of water-soluble electrolytic substances, typically containing pilocarpine, into the sweat glands using an electric stimulus (iontophoresis). It typically consists of a generator that supplies variable low-voltage electricity via two connected electrodes. After stimulus application a sweat sample is collected from the area where the positive electrode was located. The chloride and/or sodium concentration of this sweat sample is then analysed, primarily to help diagnose cystic fibrosis (CF). Devices associated with sweat collection/containment may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 435 2725info@elitechgroup.com

Regulatory Flags#

DUNS number
052423787
Device count
1
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540300400Macroduct Advanced Sweat Collection SystemModel 3710-Sys2025-02-27
03661540304156Potassium Electrode279-001279-0012023-10-01
03661540304163Chloride Electrode280-001280-0012023-10-01
03661540304170Carbon Dioxide Electrode275-001275-0012023-10-01
03661540304187Sodium Electrode278-001278-0012023-10-01
03661540300288Monosed® ESR Vacuum Tubes, CartonPRD-PRV11B-50PRD-PRV11B-502023-10-01
03661540300295Monosed® ESR Vacuum Tubes, CartonPRD-PRV11V-H12PRD-PRV11V-H122023-10-01
03661540300301Excyte® ESR Non-Vacuum Tubes, CartonEX-50100EX-501002023-10-01
03661540300318Excyte® ESR Vacuum Tubes, CartonEX-50205EX-502052023-10-01
03661540300325Excyte® ESR Vacuum Tube, CartonEP-10605EP-106052023-10-01
03661540300332Excyte® ESR Vacuum Tube, CartonEP-10605-H1EP-10605-H12023-10-01
03661540300035Microsed-System® Automated ESR AnalyzerPRD-MSS-EL-08TKNEPRD-MSS-EL-08TKNE2023-10-01
03661540300042Mix-Rate® X20 Automated ESR AnalyzerPRD-X20-EL-08TKNEPRD-X20-EL-08TKNE2023-10-01
03661540300202Monosed® ESR Vacuum TubesPRD-PRV11B-50PRD-PRV11B-502023-10-01
03661540300219Monosed® ESR Vacuum Tubes, CartonPRD-PRV11V-H12PRD-PRV11V-H122023-10-01
03661540300240Excyte® ESR Non-Vacuum TubesEX-50100EX-501002023-10-01
03661540300257Excyte® ESR Vacuum TubesEX-50205EX-502052023-10-01
03661540300264Excyte® ESR Vacuum TubeEP-10605EP-106052023-10-01
03661540300271Excyte® ESR Vacuum TubeEP-10605-H1EP-10605-H12023-10-01
03661540304286Direct A1c Control Kit55136551362023-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661540300400Macroduct Advanced Sweat Collection SystemELITECHGROUP INC.KTB2025-02-27
03661540300370Macroduct Advanced Electrode Cable AssemblyELITECHGROUP INC.KTB2021-06-07
03661540302022Nanoduct® Electrode Cable Set AssemblyELITECHGROUP INC.KTB2021-02-22
03661540301964Nanoduct® Attachment Strap Retainer Post, Qty 1ELITECHGROUP INC.KTB2021-02-19
03661540301971Nanoduct® Electrode Strap, Small, Qty 1ELITECHGROUP INC.KTB2021-02-19
03661540301988Nanoduct® Electrode Strap, Medium, Qty 1ELITECHGROUP INC.KTB2021-02-19
03661540301995Nanoduct® Electrode Strap, Large, Qty 1ELITECHGROUP INC.KTB2021-02-19
03661540302008Nanoduct® Pos (+) Red Holder, Qty 1ELITECHGROUP INC.KTB2021-02-19
03661540302015Nanoduct® Neg (-) Black Holder, Qty 1ELITECHGROUP INC.KTB2021-02-19
03661540302329Nanoduct® Supply Kit, Qty 6 ELITECHGROUP INC.KTB2021-02-19
03661540303241Nanoduct® Conductivity Sensor Cell, Qty 1 ELITECHGROUP INC.KTB2021-02-19
03661540300110Macroduct® Electrode Cable AssemblyELITECHGROUP INC.KTB2021-02-18
03661540300349Macroduct® Advanced Strap Set, Qty 18ELITECHGROUP INC.KTB2021-02-18
03661540300356Macroduct® Advanced Strap Set, Qty 180ELITECHGROUP INC.KTB2021-02-18
03661540300363Macroduct® Advanced Electrode Cable AssemblyELITECHGROUP INC.KTB2021-02-18
03661540300530Macroduct® Black Electrode Strap, Qty 1ELITECHGROUP INC.KTB2021-02-18
03661540300547Macroduct® Red Electrode Strap, Qty 1ELITECHGROUP INC.KTB2021-02-18
03661540302084Macroduct® Pilogel DiscsELITECHGROUP INC.KTB2021-02-18
03661540302152Macroduct® Supply Kit, Qty 6ELITECHGROUP INC.KTB2021-02-18
03661540302169Macroduct® Supply Kit, w/o Dye, Qty 6ELITECHGROUP INC.KTB2021-02-18
03661540302770Macroduct® Collection Strap, Small, Qty 1ELITECHGROUP INC.KTB2021-02-18
03661540302787Macroduct® Collection Strap, Medium, Qty 1ELITECHGROUP INC.KTB2021-02-18
03661540302794Macroduct® Collection Strap, Large, Qty 1ELITECHGROUP INC.KTB2021-02-18
03661540302800Macroduct® Collection Strap, XLarge, Qty 1ELITECHGROUP INC.KTB2021-02-18
03661540302817Macroduct® Collection Strap Set, S,M,L,XLELITECHGROUP INC.KTB2021-02-18
03661540302930Macroduct® Collector, Qty 1ELITECHGROUP INC.KTB2021-02-18
03661540302947Macroduct® Collector, w/o Dye, Qty 1ELITECHGROUP INC.KTB2021-02-18
03661540304378Macroduct® Advanced Supply Kit, Qty 6ELITECHGROUP INC.KTB2021-02-18
03661540304385Macroduct® Advanced Supply Kit, w/o Dye, Qty 6ELITECHGROUP INC.KTB2021-02-18
03661540303388Macroduct® Sweat Collection SystemELITECHGROUP INC.KTB2016-09-24