Colibrí™ Primary Tube for VITEK 2

Basic Information

• Brand Name: Colibrí™ Primary Tube for VITEK 2
• Primary DI: 18050148217968
• Version / Model: WR090-01-0002
• Catalog Number: WR090-01-0002
• Company Name: COPAN WASP SRL
• Labeler DUNS: 434263590
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-11-15
• Public Version: 4
• Public Version Date: 2024-01-31
• Public Version Status: Update
• Public Device Record Key: e21176c9-e970-401d-88f9-4c8e734a1545

Device Description

Colibrí™ Primary Tube for VITEK 2

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	866.1645	2
QBN	Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	866.3378	2
QQV	Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry	Microbiology	866.3378	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42651	Buffered isotonic saline reagent IVD	A buffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18050148217968	GS1
Unit of Use	58050148217966	GS1

Customer Contacts

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