Colibrí™ Primary Tube with Saline WR090-01-0011

GUDID 58052870817964

Colibrí™ Primary Tube with Saline

COPAN WASP SRL

Buffered isotonic saline reagent IVD

• Primary Device ID: 58052870817964
• NIH Device Record Key: 73705434-fe01-4ec4-bdd4-479f8c688ddf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colibrí™ Primary Tube with Saline
• Version Model Number: WR090-01-0011
• Catalog Number: WR090-01-0011
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18052870817966 [Primary]
GS1	58052870817964 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232756

FDA Product Code

• QBN: Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

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: 2024-02-08
• Device Publish Date: 2024-01-31

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: 2024-02-08Colibrí™ Primary Tube with Saline
• 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