Quantra QPlus System

Primary DI
00850003761039
Brand
Quantra QPlus System
Company
HEMOSONICS, LLC
Model
HS-002
Device description
Quantra Hemostasis Analyzer
Published
2019-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
00850003761039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003761039008500037610398500037610390850003761039

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
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003761107Quantra QPlus SystemKT-0039KT-00392021-02-11
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
00850003761213Quantra QPlus SystemKT-00232021-02-11
00850003761275Quantra QPlus SystemKT-00252021-02-11
10850003761043Quantra QPlus SystemKT-00122020-09-28
00850003761046Quantra QPlus SystemKT-00122020-09-28

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
10850003761067Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24
10850003761074Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24
10850003761081Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24