Colibrí™ Primary Tube with Water WR090-01-0003

GUDID 58050148217973

Colibrí™ Primary Tube with Water

COPAN WASP SRL

Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD

• Primary Device ID: 58050148217973
• NIH Device Record Key: 82a2f4b5-5b7d-4011-b0a1-0e292b4057e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colibrí™ Primary Tube with Water
• Version Model Number: WR090-01-0003
• Catalog Number: WR090-01-0003
• 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	18050148217975 [Primary]
GS1	58050148217973 [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

• 58050148217973 - Colibrí™ Primary Tube with Water: 2024-02-08Colibrí™ Primary Tube with Water
• 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
• 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