BreathTracker QT05004-M

GUDID 00850010197463

BreathTracker Model H2 Plus (100-120V)

QUINTRON INSTRUMENT COMPANY, INC.

Gas chromatography analyser IVD, semi-automated Gas chromatography analyser IVD, semi-automated Gas chromatography analyser IVD, semi-automated Gas chromatography analyser IVD, semi-automated Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD Gas chromatography analyser IVD

Primary Device ID	00850010197463
NIH Device Record Key	798cb802-e519-4d26-856d-0f1e391f4bbc
Commercial Distribution Status	In Commercial Distribution
Brand Name	BreathTracker
Version Model Number	H2 Plus
Catalog Number	QT05004-M
Company DUNS	874498744
Company Name	QUINTRON INSTRUMENT COMPANY, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010197463 [Primary]

FDA Product Code

NRH	System, Breath Measurement

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-05-30
Device Publish Date	2022-05-20

On-Brand Devices [BreathTracker]

00850010197463	BreathTracker Model H2 Plus (100-120V)
00850010197449	BreathTracker Model SC (100-120V)