Quantra QPlus System

Primary DI
10850003761043
Brand
Quantra QPlus System
Company
HEMOSONICS, LLC
Model
KT-0012
Device description
Quantra Cleaning Cartridge
Published
2020-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QFRCoagulation system for the measurement of whole blood viscoelastic properties

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic PropertiesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN180017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180017000Quantra Hemostasis Analyzer, QPlus CartridgeHemosonics, LLC2019-03-12QFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850003761043PrimaryGS10
00850003761046Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000376104310850003761043
00850003761046008500037610468500037610460850003761046

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation analyser IVD, point-of-care, line-poweredA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used exclusively at the point-of-care by medical professionals for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]. It may include spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection.

Regulatory Flags#

DUNS number
193921041
Device count
10
DM exempt
true
Kit
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
10850003761067Quantra QPlus SystemKT-00042019-04-24
10850003761180QStat CartridgeQStat Cartridge KIT (Box of 10)2024-02-29
00850003761336Qstat Control Level 1QStat Control Level 1 Kit (Box of 4)2024-02-29
00850003761398Qstat Control Level 2QStat Control Level 2 Kit (Box of 4)2024-02-29
00850003761183QStat CartridgeQStat Cartridge KIT (Box of 10)2024-02-29
10850003761074Quantra QPlus SystemKT-00332019-04-24
10850003761081Quantra QPlus SystemKT-00342019-04-24
00850003761107Quantra QPlus SystemKT-00392021-02-11
00850003761213Quantra QPlus SystemKT-00232021-02-11
00850003761275Quantra QPlus SystemKT-00252021-02-11
00850003761046Quantra QPlus SystemKT-00122020-09-28
00850003761039Quantra QPlus SystemHS-0022019-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850003761107Quantra QPlus SystemHEMOSONICS, LLCQFR2021-02-11
00850003761213Quantra QPlus SystemHEMOSONICS, LLCQFR2021-02-11
00850003761275Quantra QPlus SystemHEMOSONICS, LLCQFR2021-02-11
00850003761046Quantra QPlus SystemHEMOSONICS, LLCQFR2020-09-28
00850003761039Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24
10850003761067Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24
10850003761074Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24
10850003761081Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24