Quantra QPlus System

Basic Information

• Brand Name: Quantra QPlus System
• Primary DI: 10850003761067
• Version / Model: KT-0004
• Company Name: HEMOSONICS, LLC
• Labeler DUNS: 193921041
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-04-24
• Public Version: 3
• Public Version Date: 2021-02-12
• Public Version Status: Update
• Public Device Record Key: 8d8f45f9-4b32-4c7b-874e-0bdb49f79dff

Device Description

QPlus Cartridge Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QFR	Coagulation system for the measurement of whole blood viscoelastic properties	Hematology	864.5430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30595	Multiple coagulation factor IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850003761067	GS1
Unit of Use	00850003761060	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN180017	000