FDA.reportPublic FDA data

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
38
Last updated
2026-11-01 02:55:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850010197005AlveoSamplerQuintron Instrument Company, Inc.AlveoSampler2023-03-15
00850010197012GaSampler Bag, Single-PatientQuintron Instrument Company, Inc.QT00830-P2023-03-15
00850010197029BAG, GASAMPLER, DISCARD, SINGLE-PATIENTQuintron Instrument Company, Inc.QT00843-P2023-03-15
00850010197036T-CONNECTOR, PLASTICQuintron Instrument Company, Inc.QT00850-P2023-03-15
00850010197043GaSampler Kit, Single-Patient, No SubstrateQuintron Instrument Company, Inc.QT008922023-03-15
00850010197050MOUTHPIECE, 20 MM, PLASTICQuintron Instrument Company, Inc.QT00991-P2023-03-15
00850010197067EasySampler D-Xylose KitQuintron Instrument Company, Inc.QT042032023-03-15
00850010197074EasySampler, Fructose Kit, 4 TubesQuintron Instrument Company, Inc.QT042042023-03-15
00850010197098EasySampler, Lactose Kit, 4 TubesQuintron Instrument Company, Inc.QT042062023-03-15
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
00850010197289EasySampler,, Proficiency Test KitQuintron Instrument Company, Inc.QT042022023-03-15
00850010197333BAG, SAMPLE HOLDING 250 ML SINGLE PATIENTQuintron Instrument Company, Inc.QT00842-P2023-03-15
00850010197340One-Way Pediatric Sampling ValveQuintron Instrument Company, Inc.QT00859-P2023-03-15
00850010197388Syringe, 60mLQuintron Instrument Company, Inc.QT01760-V2023-03-15
00850010197401AlveoVac Collection Vials, Box of 100Quintron Instrument Company, Inc.QT026022022-05-20
00850010197432SyringeQuintron Instrument Company, Inc.QT027412023-03-15
00850010197630EASYSAMPLER ASM, 793275Quintron Instrument Company, Inc.QT016652023-03-16
00850010197678KIT, Rx, LACTULOSE, SIBO, 10T #8024Quintron Instrument Company, Inc.QT042602023-03-15
00850010197685KIT, GLUCOSE, EASYSAMPLER, 10T SIBO #8024Quintron Instrument Company, Inc.QT042632023-03-15
00850010197692KIT, SUCROSE, EASYSAMPLER, QOL, #8024Quintron Instrument Company, Inc.QT042702023-03-15
00850010197708KIT, FRUCTOSE, EASYSAMPLER, 7T #8024Quintron Instrument Company, Inc.QT042652023-03-15
00850010197715KIT, SUCROSE, EASYSAMPLER, 7T, #8024Quintron Instrument Company, Inc.QT042642023-03-15
00850010197722KIT, LACTOSE, EASYSAMPLER, 7T, #8024Quintron Instrument Company, Inc.QT042662023-03-15
10850010197088EasySampler, Lactulose Kit, 10 Tubes, RxQuintron Instrument Company, Inc.QT042052023-03-15
10850010197118EasySampler, No Substrate Kit, 7 TubeQuintron Instrument Company, Inc.QT042092023-03-15
10850010197125EasySampler, Glucose Kit, 10 TubesQuintron Instrument Company, Inc.QT042102023-03-15
10850010197132EasySampler, Sucrose Kit, 7 TubesQuintron Instrument Company, Inc.QT042142023-03-15
10850010197583EasySampler, No Substrate Kit, 4 TubesQuintron Instrument Company, Inc.QT042082023-03-15
00842472100839MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCMS9902016-09-23
00842472100846MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCMS9942016-09-23
00842472103014MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCMSB15002016-09-23
00842472103021MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCMSR15002016-09-23