Colibrí™ System

Basic Information

• Brand Name: Colibrí™ System
• Primary DI: 58052870816202
• Version / Model: W090.US
• Catalog Number: W090.US
• Company Name: COPAN WASP SRL
• Labeler DUNS: 434263590
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-27
• Public Version: 3
• Public Version Date: 2023-04-13
• Public Version Status: Update
• Public Device Record Key: 0ab20953-56b5-4ab9-b1f1-89b49992b5f3
• Distribution End Date: 2023-03-20

Device Description

Colibrí™ System

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: Yes
• 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
QQV	Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry	Microbiology	866.3378	2
QBN	Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	866.3378	2
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	866.1645	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61712	Microbial specimen inoculation/streaking/colony-picking instrument IVD	An electrically-powered instrument intended for the pre-analytical preparation of microbial samples (e.g., cultures, suspensions, MALDI-TOF targets/slides) from a clinical specimen and/or culture isolate. Its functionality includes: 1) automated/semi-automated transfer of the clinical specimen (e.g., by aspiration or inoculating loop), inoculation into/onto culture dishes/tubes/slides, and streaking of culture dishes (e.g., using magnetic beads, inoculation loops or spreaders); and/or 2) automated microbial colony picking for the preparation of samples for subsequent analytical procedures. It may also feature processing capabilities such as barcoding, storage, and/or sorting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	58052870816202	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193138	000
K220546	000