FDA.reportPublic FDA data

AlveoVac Collection Vials, Box of 100

Primary DI
00850010197401
Brand
AlveoVac Collection Vials, Box of 100
Company
QUINTRON INSTRUMENT COMPANY, INC.
Model
QT02602
Catalog number
QT02602
Device description
ALVEOVAC, COLLECTION VIALS, BOX OF 100
Published
2022-05-20
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
00850010197401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010197401008500101974018500101974010850010197401

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
Manufacturing date on label
true
Expiration 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
00860009311602RTubeRespiratory Research IncKGK2023-11-21
06950471300151GAS COLLECTING VESSELHangzhou A-Tek Medical & Textiles Co., Ltd.KGK2023-07-21
00850010197005AlveoSamplerQUINTRON INSTRUMENT COMPANY, INC.KGK2023-03-15
00850010197432Syringe QUINTRON INSTRUMENT COMPANY, INC.KGK2023-03-15