BreathTracker QT05004-M

GUDID 00850010197463

BreathTracker Model H2 Plus (100-120V)

QUINTRON INSTRUMENT COMPANY, INC.

Gas chromatography analyser IVD, semi-automated

• 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)