Colibri Spreader

Basic Information

• Brand Name: Colibri Spreader
• Primary DI: 18050148212864
• Version / Model: WR090-01-0605T
• Catalog Number: WR090-01-0605T
• Company Name: COPAN WASP SRL
• Labeler DUNS: 434263590
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• 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: e05dd155-da37-42a7-a765-38d18c996c70

Device Description

Colibri Spreader

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: No
• Has Lot/Batch Number: Yes
• 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
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
63707	Inoculating tool IVD, analyser/instrument	A component of an automated/semi-automated in vitro diagnostic laboratory analyser or instrument intended to be used onboard to collect, transfer and spread an inoculum from a clinical specimen and/or culture isolate onto/into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It is typically made of sterilizable materials (e.g., plastic, metal) and consists of a shaft with a loop, wand, or swab at one or both ends. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18050148212864	GS1
Unit of Use	58050148212862	GS1

Customer Contacts

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