Agento™ I.C.® Silver-Coated Endotracheal Tube 500385

GUDID 10801741067317

Agento Endotracheal Tubes, Coated

C. R. Bard, Inc.

Antimicrobial endotracheal tube

• Primary Device ID: 10801741067317
• NIH Device Record Key: 33e445e4-f4c0-408d-bebf-c42eeeb993a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Agento™ I.C.® Silver-Coated Endotracheal Tube
• Version Model Number: 500385
• Catalog Number: 500385
• Company DUNS: 016898496
• Company Name: C. R. Bard, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com

Device Dimensions

• Lumen/Inner Diameter: 8.5 Millimeter
• Lumen/Inner Diameter: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741067310 [Primary]
GS1	10801741067317 [Package]; Contains: 00801741067310; Package: CA [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071365

FDA Product Code

• BTR: Tube, tracheal (w/wo connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-01-25

On-Brand Devices [Agento™ I.C.® Silver-Coated Endotracheal Tube]

• 10801741067331: Agento Endotracheal Tubes, Coated
• 10801741067324: Agento Endotracheal Tubes, Coated
• 10801741067317: Agento Endotracheal Tubes, Coated
• 10801741067300: Agento Endotracheal Tubes, Coated
• 10801741067294: Agento Endotracheal Tubes, Coated
• 10801741067287: Agento Endotracheal Tubes, Coated
• 10801741067270: Agento Endotracheal Tubes, Coated
• 10801741067263: Agento Endotracheal Tubes, Coated