Colibrí™ Primary Tube for VITEK 2 WR090-01-0002

GUDID 18050148217968

Colibrí™ Primary Tube for VITEK 2

COPAN WASP SRL

Buffered isotonic saline reagent IVD

• Primary Device ID: 18050148217968
• NIH Device Record Key: e21176c9-e970-401d-88f9-4c8e734a1545
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colibrí™ Primary Tube for VITEK 2
• Version Model Number: WR090-01-0002
• Catalog Number: WR090-01-0002
• Company DUNS: 434263590
• Company Name: COPAN WASP SRL
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18050148217968 [Primary]
GS1	58050148217966 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220546

FDA Product Code

• LON: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-23
• Device Publish Date: 2022-11-15

Devices Manufactured by COPAN WASP SRL

• 58059796363933 - WASPLab®: 2024-06-12 WASPLab®
• 58059796363940 - WASPLab® Conveyor: 2024-06-12 WASPLab® Conveyor
• 58059796363957 - WASPLab® Single Incubator: 2024-06-12 WASPLab® Single Incubator
• 58059796363964 - WASPLab® Double Incubator: 2024-06-12 WASPLab® Double Incubator
• 58050148217973 - Colibrí™ Primary Tube with Water: 2024-02-08 Colibrí™ Primary Tube with Water
• 58052870817964 - Colibrí™ Primary Tube with Saline: 2024-02-08 Colibrí™ Primary Tube with Saline
• 58059796361700 - URIVerse™: 2023-10-30 URIVerse™
• 08050148218005 - Colibri Daily Verification Kit: 2022-11-23 Colibri Daily Verification Kit