QStat Cartridge

Basic Information

• Brand Name: QStat Cartridge
• Primary DI: 10850003761180
• Version / Model: QStat Cartridge KIT (Box of 10)
• Company Name: HEMOSONICS, LLC
• Labeler DUNS: 193921041
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-02-29
• Public Version: 1
• Public Version Date: 2024-03-08
• Public Version Status: New
• Public Device Record Key: 40e1a072-6851-4fc0-ace9-f7c7e9f8eba5

Device Description

For Use with the QUANTRA® Hemostasis Analyzer

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
56689	Coagulation analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850003761183	GS1
Primary	10850003761180	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K213917	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 28 Degrees Celsius