Trachealator

GUDID 06009698450009

The Trachealator Non-occlusive Airway Dilation Balloon is comprised of a single lumen, over-the wire, catheter with a clustered balloon system near the distal tip. The balloon cluster, when inflated, features a inter balloon space to avoid airway occlusion during deployment. The inflated balloon cluster generates a strong outward force for dilation of airway strictures. A guidewire is provided to facilitate the advancement of the Trachealator Non-occlusive Airway Dilation Balloon to the desired location.

DISA MEDINOTEC (PTY) LTD

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• Primary Device ID: 06009698450009
• NIH Device Record Key: ac4a1c3f-d03c-4d30-bdf5-384da1c0b14e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trachealator
• Version Model Number: TRD1
• Company DUNS: 539157634
• Company Name: DISA MEDINOTEC (PTY) LTD
• 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06009698450009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211894

FDA Product Code

• KTI: Bronchoscope Accessory

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-10
• Device Publish Date: 2023-08-02