Quantra QPlus System

GUDID 00850003761213

QPlus Control Level 1 Kit

HEMOSONICS, LLC

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 Coagulation analyser IVD, point-of-care, line-powered

• Primary Device ID: 00850003761213
• NIH Device Record Key: bb0f3e7b-032d-4222-af72-bc6f6a5e9799
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantra QPlus System
• Version Model Number: KT-0023
• Company DUNS: 193921041
• Company Name: HEMOSONICS, LLC
• Device Count: 1
• 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: true
• 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	00850003761213 [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: 2021-02-19
• Device Publish Date: 2021-02-11

On-Brand Devices [Quantra QPlus System]

• 00850003761046: Quantra Cleaning Cartridge
• 00850003761275: QPlus Control Level 2 Kit
• 00850003761213: QPlus Control Level 1 Kit
• 00850003761107: Quantra Desktop Remote Viewer