GaSampler Kit, Single-Patient, No Substrate QT00892

GUDID 00850010197043

KIT, GASAMPLER SINGLE-PT, NO SUBSTRATE

QUINTRON INSTRUMENT COMPANY, INC.

Breath specimen container IVD

• Primary Device ID: 00850010197043
• NIH Device Record Key: 762a96e8-177c-438e-b910-2d2376b41daa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GaSampler Kit, Single-Patient, No Substrate
• Version Model Number: QT00892
• Catalog Number: QT00892
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	00850010197043 [Primary]
GS1	00850010197890 [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: 2023-03-23 BAG, COLLECTION, GASAMPLER, SINGLE PATIENT