AccessGUDID - DEVICE: Macroduct® Advanced 3710 Sweat Collection System (03661540304347)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 03661540304347
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052423787 *Terms of Use

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.

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):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	Yes
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: 181ff4c5-5bdc-4984-beca-168f8623e74f
Public Version Date: February 23, 2021
Public Version Number: 3
DI Record Publish Date: October 11, 2018