AccessGUDID - DEVICE: Macroduct Advanced Sweat Collection System (03661540300400)

GUDID

Device Identifier (DI) Information

Brand Name: Macroduct Advanced Sweat Collection System
Version or Model: Model 3710-Sys
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ELITECHGROUP INC.

Primary DI Number: 03661540300400
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052423787 *Terms of Use

Device Description: The Macroduct Advanced Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
15128	Sweat-induction iontophoresis system	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTB	Device, Iontophoresis, Specific Uses

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180627	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0931b7c0-059d-4967-b9ab-f180df2e3bef
Public Version Date: March 07, 2025
Public Version Number: 1
DI Record Publish Date: February 27, 2025