Unyvero

Basic Information

• Brand Name: Unyvero
• Primary DI: 04260364750027
• Version / Model: C8 Cockpit
• Catalog Number: 60003
• Company Name: Curetis GmbH
• Labeler DUNS: 312621863
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-28
• Public Version: 4
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: f957d17a-83e4-4478-bf7d-60d30f874149

Device Description

User interface and instrument to control Unyvero Application workflow in combination with Unyvero L4 Lysator(s) and Unyvero A50 Analyzer(s)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QBH	Lower respiratory microbial nucleic acid detection system	Microbiology	866.3985	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61302	Laboratory instrument/analyser control unit IVD	An electrically-powered device intended to be used to control one or multiple in vitro diagnostic laboratory analyser(s)/instrument(s) used in the processing/preparation/analysis of a clinical specimen. It is designed to enable the user to input/manipulate sample data and select assays to be performed. The device consists of a combination of dedicated and off-the-shelf hardware [e.g., personal computer (PC), keyboard mouse and/or graphical user interface (GUI) touchscreen monitor] and software. It may include network components for the management and distribution of associated medical data (e.g., images, test results, patient-specific data) within or between healthcare facilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260364750027	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity