FDA.reportPublic FDA data

Syringe

Primary DI
00850010197432
Brand
Syringe
Company
QUINTRON INSTRUMENT COMPANY, INC.
Model
QT02741
Catalog number
QT02741
Published
2023-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KGKGas, Collecting Vessel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGKGas, Collecting VesselAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010197432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010197432008500101974328500101974320850010197432

GMDN Terms#

Term, Definition table
TermDefinition
Breath specimen container IVDA container (e.g., bag, tube) 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 may include a port for blowing into the container, 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
874498744
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850010197999BT UPGRADE, CUI, INC POWER SUPPLIESQT06011-UP2025-03-19
00850010197029BAG, GASAMPLER, DISCARD, SINGLE-PATIENTQT00843-PQT00843-P2023-03-15
00850010197036T-CONNECTOR, PLASTICQT00850-PQT00850-P2023-03-15
00850010197050MOUTHPIECE, 20 MM, PLASTICQT00991-PQT00991-P2023-03-15
00850010197142SUGAR, DEXTROSE (GLUCOSE), 75 GM PACKETQT02300-75-SQT02300-75-S2023-03-15
00850010197159SUGAR, Rx, GLUCOSE, 100 GM / 10 OZ, LIQUIDQT02350-100-SQT02350-100-S2023-03-15
00850010197166SUGAR, LACTOSE, LACTEST, 25 GM, PACKETQT02425-SQT02425-S2023-03-15
00850010197173SUGAR, Rx, LACTULOSE, 10G/15ML SYRUPQT02500-10-SQT02500-10-S2023-03-15
00850010197180SUGAR, SUCROSE, 50 GM PACKETQT02600-50-SQT02600-50-S2023-03-15
00850010197197SUGAR, D-XYLOSE, 25 GM, PACKETQT02700-25-SSQT02700-25-S2023-03-15
00850010197203SUGAR, FRUCTOSE, 25 GM, PACKETQT02900-25-SQT02900-25-S2023-03-15
00850010197333BAG, SAMPLE HOLDING 250 ML SINGLE PATIENTQT00842-PQT00842-P2023-03-15
00850010197630EASYSAMPLER ASM, 793275QT01665QT016652023-03-16
00850010197005AlveoSamplerAlveoSamplerQT00827-P2023-03-15
00850010197012GaSampler Bag, Single-PatientQT00830-PQT00830-P2023-03-15
00850010197043GaSampler Kit, Single-Patient, No SubstrateQT00892QT008922023-03-15
00850010197067EasySampler D-Xylose KitQT04203QT042032023-03-15
00850010197074EasySampler, Fructose Kit, 4 TubesQT04204QT042042023-03-15
00850010197081EasySampler, Lactulose Kit, 10 Tubes, RxQT04205QT042052023-03-15
00850010197098EasySampler, Lactose Kit, 4 TubesQT04206QT042062023-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009311602RTubeRespiratory Research IncKGK2023-11-21
06950471300151GAS COLLECTING VESSELHangzhou A-Tek Medical & Textiles Co., Ltd.KGK2023-07-21
00850010197005AlveoSamplerQUINTRON INSTRUMENT COMPANY, INC.KGK2023-03-15
00850010197401AlveoVac Collection Vials, Box of 100QUINTRON INSTRUMENT COMPANY, INC.KGK2022-05-20