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
Rx
false
OTC
false
Sterile
false
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, 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.

Regulatory Flags#

DUNS number
874498744
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850066504086STOPCOCK, ONE-WAY, PLASTICQT01727-VQT01727-V2023-03-15
10850010197088EasySampler, Lactulose Kit, 10 Tubes, RxQT04205QT042052023-03-15
10850010197118EasySampler, No Substrate Kit, 7 TubeQT04209QT042092023-03-15
10850010197125EasySampler, Glucose Kit, 10 TubesQT04210QT042102023-03-15
10850010197132EasySampler, Sucrose Kit, 7 TubesQT04214QT042142023-03-15
10850010197583EasySampler, No Substrate Kit, 4 TubesQT04208QT042082023-03-15
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
00850010197234DUST BARRIER, 5 PACKQT01140-KQT01140-K2023-03-15
00850010197272VIAL ADAPTER, PLASTIC, 5 PACKQT02688QT026882023-03-15
00850010197333BAG, SAMPLE HOLDING 250 ML SINGLE PATIENTQT00842-PQT00842-P2023-03-15
00850010197630EASYSAMPLER ASM, 793275QT01665QT016652023-03-16

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
00850010197432SyringeQuintron Instrument Company, Inc.KGK2023-03-15