GaSampler Bag, Single-Patient QT00830-P

GUDID 00850010197012

BAG, COLLECTION, GASAMPLER, SINGLE PATIENT

QUINTRON INSTRUMENT COMPANY, INC.

Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD

• Primary Device ID: 00850010197012
• NIH Device Record Key: ff504b63-1186-4c30-9617-3f0e15c629b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GaSampler Bag, Single-Patient
• Version Model Number: QT00830-P
• Catalog Number: QT00830-P
• Company DUNS: 874498744
• Company Name: QUINTRON INSTRUMENT COMPANY, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00850010197012 [Primary]
GS1	00850010197739 [Unit of Use]

FDA Product Code

• NNI: Container, Specimen, Non-Sterile

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: 2023-03-23
• Device Publish Date: 2023-03-15

Devices Manufactured by QUINTRON INSTRUMENT COMPANY, INC.

• 00850010197982 - SUGAR, Rx, LACTULOSE, 10 GM SYRUP, USP: 2024-03-26
• 00850010197937 - LOANER ALVEOVAC EXTRACTOR: 2023-03-27
• 00850010197944 - EXTRACTOR REPAIR: 2023-03-27
• 00850010197920 - EASYSAMPLER ASM, 793275: 2023-03-24
• 00850010197906 - BT GC LOANER SC: 2023-03-24
• 00850010197913 - BREATHTRACKER SERIES REPAIR: 2023-03-24
• 00850010197005 - AlveoSampler: 2023-03-23 KIT, ALVEOSAMPLER ONLY, NO SUBSTRATE
• 00850010197012 - GaSampler Bag, Single-Patient: 2023-03-23BAG, COLLECTION, GASAMPLER, SINGLE PATIENT
• 00850010197012 - GaSampler Bag, Single-Patient: 2023-03-23 BAG, COLLECTION, GASAMPLER, SINGLE PATIENT