Qunatra QPlus System

GUDID 00850003761039

Quantra Hemostasis Analyzer

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

• Primary Device ID: 00850003761039
• NIH Device Record Key: 5f0f1bbe-1ce6-4c9a-a6c7-ee33cf69ab80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qunatra QPlus System
• Version Model Number: HS-002
• Company DUNS: 193921041
• Company Name: HEMOSONICS, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00850003761039 [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