Bivona

GUDID 10887709128566

XT24HS35NGZ006N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile

ICU MEDICAL, INC.

Tracheostomy tube, reinforced, non-customized, reusable

• Primary Device ID: 10887709128566
• NIH Device Record Key: 3ca3e948-1ee7-4c36-b904-524ebb12f392
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bivona
• Version Model Number: XT24HS35NGZ006N
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887709128566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923878

FDA Product Code

• JOH: Tube tracheostomy and tube cuff

Sterilization

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

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

[10887709128566]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-09
• Device Publish Date: 2024-10-01

On-Brand Devices [Bivona]

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• 10887709128597: FT24HN35NGA015N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128580: FT24HN55NSF008N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128573: AU24HS80NSC007N Bivona DI Template: Adjustable Non-Sterile
• 10887709128566: XT24HS35NGZ006N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128559: FT24HN35NGE005N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128542: FT24HN60NGF004N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128535: FT24GN25NSA003N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128528: FT24GN35NSE226NBivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128511: FT24GN35NGE078N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile