FDA.reportPublic FDA data

AlveoSampler

Primary DI
00850010197005
Brand
AlveoSampler
Company
Quintron Instrument Company, Inc.
Model
AlveoSampler
Catalog number
QT00827-P
Device description
KIT, ALVEOSAMPLER ONLY, NO SUBSTRATE
Published
2023-03-15
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
00850010197005PrimaryGS10
00850010197845Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010197005008500101970058500101970050850010197005
00850010197845008500101978458500101978450850010197845

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
10
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
false
Expiration date on label
false
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
00850010197432SyringeQuintron Instrument Company, Inc.KGK2023-03-15
00850010197401AlveoVac Collection Vials, Box of 100Quintron Instrument Company, Inc.KGK2022-05-20