AccessGUDID - DEVICE: Patient Sample Drying Tube (00850010197227)

GUDID

Device Identifier (DI) Information

Brand Name: Patient Sample Drying Tube
Version or Model: QT01135-K
Commercial Distribution Status: In Commercial Distribution
Catalog Number: QT01135-K
Company Name: QUINTRON INSTRUMENT COMPANY, INC.

Primary DI Number: 00850010197227
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 874498744 *Terms of Use

Device Description: DRYING TUBE, PATIENT SAMPLE

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?
57843	Gas chromatography analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. Volatile components are separated in a gaseous mixture based on their partitioning differences between mobile and stationary phases as they pass through a column. As the substances exit the column they are detected and identified electronically or spectrometrically, based on their structure. The analyser is typically used for the identification of complex substances such as drugs and hormones.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRH	System, Breath Measurement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 68332606-d6e5-4a7b-8311-7681878f34a6
Public Version Date: March 23, 2023
Public Version Number: 1
DI Record Publish Date: March 15, 2023