Quantra QPlus System

Primary DI
10850003761074
Brand
Quantra QPlus System
Company
HEMOSONICS, LLC
Model
KT-0033
Device description
Quantra Quality Control Level 1 Kit
Published
2019-04-24
Public version status
Update
Distribution status
Not 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
10850003761074PrimaryGS10
00850003761077Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000376107410850003761074
00850003761077008500037610778500037610770850003761077

GMDN Terms#

Term, Definition table
TermDefinition
Medicine chamber spacer, single-useA non-sterile device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic, paper, or cardboard and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise be deposited in the mouth/upper airway, but are intended for the lower airway. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
193921041
Device count
4
DM exempt
true
Kit
true
Lot or batch
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
10850003761081Quantra QPlus SystemKT-00342019-04-24
00850003761107Quantra QPlus SystemKT-00392021-02-11
00850003761213Quantra QPlus SystemKT-00232021-02-11
00850003761275Quantra QPlus SystemKT-00252021-02-11
10850003761043Quantra QPlus SystemKT-00122020-09-28
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
10850003761043Quantra QPlus SystemHEMOSONICS, LLCQFR2020-09-28
00850003761046Quantra QPlus SystemHEMOSONICS, LLCQFR2020-09-28
00850003761039Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24
10850003761067Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24
10850003761081Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24