AccessGUDID - DEVICE: Unyvero (04260364750027)

GUDID

Device Identifier (DI) Information

Brand Name: Unyvero
Version or Model: C8 Cockpit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60003
Company Name: Curetis GmbH

Primary DI Number: 04260364750027
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 312621863 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QBH	Lower respiratory microbial nucleic acid detection system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f957d17a-83e4-4478-bf7d-60d30f874149
Public Version Date: February 03, 2025
Public Version Number: 5
DI Record Publish Date: May 28, 2018