AccessGUDID - DEVICE: Take-up Tubes, 14 inch, Qty 100 (03661540302336)

GUDID

Device Identifier (DI) Information

Brand Name: Take-up Tubes, 14 inch, Qty 100
Version or Model: SS-044
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ELITECHGROUP INC.

Primary DI Number: 03661540302336
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052423787 *Terms of Use

Device Description: The Take-up tubes are intended to be used with the 3120 SWEAT•CHEK Sweat Conductivity Analyzer for sweat analysis for the laboratory diagnosis of cystic fibrosis. The tubes allow for a sweat specimen as small as 6 to 10 microliters to be measured.

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:	Yes
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?
60268	Sweat conductivity analyser IVD	A portable, electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of the electrical conductivity of a sweat specimen, as an indicator of total electrolyte concentration, by measuring the ease at which an electric current passes between two points of a conductor in a flow-through cell maintained at a precisely controlled temperature. Calibration solutions and controls are used to validate these results which are typically used to help diagnose cystic fibrosis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGZ	Electrode, Ion-Specific, Chloride

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K863395	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: 5a7988d6-a9a7-4a85-92e1-bdbc1003dfb8
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: February 19, 2021