Colibri Daily Verification Kit WR090-01-0004

GUDID 08050148218005

Colibri Daily Verification Kit

COPAN WASP SRL

Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use

• Primary Device ID: 08050148218005
• NIH Device Record Key: ee2e81a5-48e2-4f59-9dd2-609f7174a999
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colibri Daily Verification Kit
• Version Model Number: WR090-01-0004
• Catalog Number: WR090-01-0004
• Company DUNS: 434263590
• Company Name: COPAN WASP SRL
• Device Count: 2
• 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: false
• 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	08050148218005 [Primary]
GS1	58050148218000 [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

• 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: 2022-11-23Colibri Daily Verification Kit
• 08050148218005 - Colibri Daily Verification Kit: 2022-11-23 Colibri Daily Verification Kit
• 18050148212864 - Colibri Spreader: 2022-11-23 Colibri Spreader
• 18050148217968 - Colibrí™ Primary Tube for VITEK 2: 2022-11-23 Colibrí™ Primary Tube for VITEK 2
• 58050148218208 - Colibrí™: 2022-11-23 Colibrí™
• 58052870818923 - External Loader - Turn Table: 2022-06-03 External Loader - Turn Table