Cuffix

GUDID 17290017345038

The Cuffix is intended to measure and regulate, through passive control, intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.

BIOVO TECHNOLOGIES LTD

Endotracheal tube cuff inflator

• Primary Device ID: 17290017345038
• NIH Device Record Key: fe8f60d9-a3bc-40fd-b903-b8545f63a95c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cuffix
• Version Model Number: 02
• Company DUNS: 600248533
• Company Name: BIOVO TECHNOLOGIES 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: 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: +972722151115
• Email: info@biovo-tech.com
• Phone: +972722151115
• Email: info@biovo-tech.com
• Phone: +972722151115
• Email: info@biovo-tech.com
• Phone: +972722151115
• Email: info@biovo-tech.com
• Phone: +972722151115
• Email: info@biovo-tech.com
• Phone: +972722151115
• Email: info@biovo-tech.com
• Phone: +972722151115
• Email: info@biovo-tech.com
• Phone: +972722151115
• Email: info@biovo-tech.com
• Phone: +972722151115
• Email: info@biovo-tech.com
• Phone: +972722151115
• Email: info@biovo-tech.com
• Phone: +972722151115
• Email: info@biovo-tech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017345031 [Primary]
GS1	17290017345038 [Package]; Contains: 07290017345031; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192611

FDA Product Code

• BSK: Cuff, Tracheal Tube, Inflatable

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: 2021-01-11
• Device Publish Date: 2021-01-03

On-Brand Devices [Cuffix]

• 07290017345017: The Cuffix is intended to measure and regulate, through passive control, intracuff pressure of E
• 17290017345038: The Cuffix is intended to measure and regulate, through passive control, intracuff pressure of E