FDA.reportPublic FDA data

AlveoVac Exraction System-USA 24VDC

Primary DI
00850010197500
Brand
AlveoVac Exraction System-USA 24VDC
Company
QUINTRON INSTRUMENT COMPANY, INC.
Model
QT05200-M
Catalog number
QT05200-M
Device description
A stand-alone accessory which extracts breath samples from approved QuinTron breath collection devices and injects the sample into the BreathTracker SC or H2+ breath analyzer. Approved QuinTron collection devices include our following products: 10ml AlveoVac glass vials, sample holding bags, and QuinTron syringes.
Published
2023-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NRHSystem, Breath Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRHSystem, Breath MeasurementClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010197500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010197500008500101975008500101975000850010197500

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser pump IVDAn electromechanical component of a laboratory instrument/analyser used for in vitro diagnostic procedures [e.g., high performance liquid chromatograph (HPLC), coagulation analyser] designed to produce positive and negative (vacuum) pressure during analyser/instrument operation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
874498744
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
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
00850010197999BT UPGRADE, CUI, INC POWER SUPPLIESQUINTRON INSTRUMENT COMPANY, INC.NRH2025-03-19
00860006377830Pure Comfort Breath ExerciserHOME AIDE DIAGNOSTICS, INC.NRH2024-10-08
10860006377837Pure Comfort Breath ExerciserHOME AIDE DIAGNOSTICS, INC.NRH2024-10-08
00850010197982SUGAR, Rx, LACTULOSE, 10 GM SYRUP, USPQUINTRON INSTRUMENT COMPANY, INC.NRH2024-03-18
05060246860399GastrolyzerBEDFONT SCIENTIFIC LIMITEDNRH2023-06-15
05060246860108GastrolyzerBEDFONT SCIENTIFIC LIMITEDNRH2023-06-08
05060246860153GastrolyzerBEDFONT SCIENTIFIC LIMITEDNRH2023-06-08
00850010197937LOANER ALVEOVAC EXTRACTORQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-17
00850010197944EXTRACTOR REPAIRQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-17
00850010197906BT GC LOANER SCQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-16
00850010197913BREATHTRACKER SERIES REPAIRQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-16
00850010197234DUST BARRIER, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197272VIAL ADAPTER, PLASTIC, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197371STOPCOCK, ONE-WAY, PLASTICQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197210FILTER, FOAM PLUG, 10 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197227Patient Sample Drying TubeQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197869DUST BARRIER, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197265SX2 Plus Maintenance KitQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197876VIAL ADAPTER, PLASTIC, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197302Tank Support, Safety, Table-Top PlasticQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197357Drying Tube End, Sample Inlet, FemaleQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197364Drying Tube End, Sample Inlet, MaleQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197883STOPCOCK, ONE-WAY, PLASTICQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197395SivRite-4 Tubing AssemblyQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197418Screwdriver, Valve Removal ToolQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197456Extraction System Output TubingQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197258BreathPrep DesiccantQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20
00850010197449BreathTrackerQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20
00850010197463BreathTrackerQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20