BreathTracker

Basic Information

• Brand Name: BreathTracker
• Primary DI: 00850010197449
• Version / Model: SC
• Catalog Number: QT05000-M
• Company Name: QUINTRON INSTRUMENT COMPANY, INC.
• Labeler DUNS: 874498744
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-20
• Public Version: 2
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: e8f8ecd7-3e5f-4343-9d20-7e98f57b30b9

Device Description

BreathTracker Model SC (100-120V)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRH	System, Breath Measurement	Clinical Chemistry	862.1820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850010197449	GS1