TRACOE® technic

GUDID 04035324015078

TRACOE cuff pressure monitor

Tracoe medical GmbH

Endotracheal tube cuff inflator

• Primary Device ID: 04035324015078
• NIH Device Record Key: 33928556-5f2b-4f4a-a6f7-100a5b87e2aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACOE® technic
• Version Model Number: REF 720
• Company DUNS: 319414785
• Company Name: Tracoe medical GmbH
• 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: false
• 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: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com
• Phone: +49613691690
• Email: info@tracoe.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *The products must be stored in a cool and dry location. Temporary storage for = 30 days at = +50 °C is possible. Protect the product from sunlight and extreme cold.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035324015078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152778

FDA Product Code

• BSK: Cuff, tracheal tube, inflatable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2025-04-10
• Device Publish Date: 2017-01-23

On-Brand Devices [TRACOE® technic]

• 04035324046317: TRACOE Connection tube
• 04035324019496: TRACOE smart Cuff Manager
• 04035324015078: TRACOE cuff pressure monitor