AMSure® Endotracheal Tube AS72045

GUDID 10704411002437

AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line

AMSINO INTERNATIONAL, INC.

Basic endotracheal tube, single-use

• Primary Device ID: 10704411002437
• NIH Device Record Key: 9d6c07c1-3954-456e-bb93-482d14e06d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Endotracheal Tube
• Version Model Number: 1
• Catalog Number: AS72045
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• Device Count: 1
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411002437 [Primary]
GS1	30704411002431 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	40704411002438 [Package]; Contains: 30704411002431; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042683

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: 2019-12-23
• Device Publish Date: 2016-09-23

On-Brand Devices [AMSure® Endotracheal Tube]

• 40704411006115: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 40704411006108: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 40704411006092: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411006084: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002543: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002536: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002529: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002512: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002505: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002499: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002482: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002475: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002468: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002451: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002444: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002437: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line
• 10704411002420: AMSure® Endotracheal Tube with Cuff, High Volume, Low Pressure, Radiopaque Line