Qunatra QPlus System

GUDID 10850003761067

QPlus Cartridge Kit

HEMOSONICS, LLC

Medicine chamber spacer, single-use Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent Multiple coagulation factor IVD, reagent

• Primary Device ID: 10850003761067
• NIH Device Record Key: 8d8f45f9-4b32-4c7b-874e-0bdb49f79dff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qunatra QPlus System
• Version Model Number: KT-0004
• Company DUNS: 193921041
• Company Name: HEMOSONICS, LLC
• Device Count: 10
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003761060 [Unit of Use]
GS1	10850003761067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN180017

FDA Product Code

• QFR: Coagulation system for the measurement of whole blood viscoelastic properties

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-02
• Device Publish Date: 2019-04-24

On-Brand Devices [Qunatra QPlus System]

• 10850003761081: Quantra Quality Control Level 2 Kit
• 10850003761074: Quantra Quality Control Level 1 Kit
• 10850003761067: QPlus Cartridge Kit
• 00850003761039: Quantra Hemostasis Analyzer