Breath specimen container IVD

Definition
A container (e.g., bag, tube, collection card) intended to contain a specimen of air exhaled from a patient for subsequent in vitro determination of chemical and/or biological markers (e.g., volatile organic compounds) in the specimen to aid metabolic profiling or the diagnosis of disorders [e.g., lipid peroxidation levels, gastrointestinal H. pylori infection, coronavirus disease (COVID-19) infection]. It typically consists of carbon dioxide (CO2) absorbing material which may be encased within the container, a port/mouthpiece or an access device (e.g., tubing) to facilitate specimen collection, and/or an adaptor for connection to an analyser. This is a single-use device.
GUDID devices
16
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00842472100839MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCMS9902016-09-23
00842472100846MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCMS9942016-09-23
00842472103014MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCMSB15002016-09-23
00842472103021MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCMSR15002016-09-23
00850010197029BAG, GASAMPLER, DISCARD, SINGLE-PATIENTQUINTRON INSTRUMENT COMPANY, INC.QT00843-P2023-03-15
00850010197036T-CONNECTOR, PLASTICQUINTRON INSTRUMENT COMPANY, INC.QT00850-P2023-03-15
00850010197050MOUTHPIECE, 20 MM, PLASTICQUINTRON INSTRUMENT COMPANY, INC.QT00991-P2023-03-15
00850010197142SUGAR, DEXTROSE (GLUCOSE), 75 GM PACKETQUINTRON INSTRUMENT COMPANY, INC.QT02300-75-S2023-03-15
00850010197159SUGAR, Rx, GLUCOSE, 100 GM / 10 OZ, LIQUIDQUINTRON INSTRUMENT COMPANY, INC.QT02350-100-S2023-03-15
00850010197166SUGAR, LACTOSE, LACTEST, 25 GM, PACKETQUINTRON INSTRUMENT COMPANY, INC.QT02425-S2023-03-15
00850010197173SUGAR, Rx, LACTULOSE, 10G/15ML SYRUPQUINTRON INSTRUMENT COMPANY, INC.QT02500-10-S2023-03-15
00850010197180SUGAR, SUCROSE, 50 GM PACKETQUINTRON INSTRUMENT COMPANY, INC.QT02600-50-S2023-03-15
00850010197197SUGAR, D-XYLOSE, 25 GM, PACKETQUINTRON INSTRUMENT COMPANY, INC.QT02700-25-SS2023-03-15
00850010197203SUGAR, FRUCTOSE, 25 GM, PACKETQUINTRON INSTRUMENT COMPANY, INC.QT02900-25-S2023-03-15
00850010197333BAG, SAMPLE HOLDING 250 ML SINGLE PATIENTQUINTRON INSTRUMENT COMPANY, INC.QT00842-P2023-03-15
00850010197630EASYSAMPLER ASM, 793275QUINTRON INSTRUMENT COMPANY, INC.QT016652023-03-16