TRACOE technic REF 730-5

GUDID 04035324019632

TRACOE smart Cuff Manager

Tracoe medical GmbH

Endotracheal tube cuff inflator

• Primary Device ID: 04035324019632
• NIH Device Record Key: 6dc820cf-c95e-489e-ab20-7a472f116002
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACOE technic
• Version Model Number: REF 730-5
• Catalog Number: REF 730-5
• Company DUNS: 319414785
• Company Name: Tracoe medical GmbH
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035324019632 [Primary]
GS1	05701780328449 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152865

FDA Product Code

• BSK: Cuff, tracheal tube, inflatable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2024-11-29
• Device Publish Date: 2017-01-23

Devices Manufactured by Tracoe medical GmbH

• 04035324012176 - TRACOE® care: 2025-05-01 TRACOE cleaning brushes with wool tip
• 04035324012183 - TRACOE® care: 2025-05-01 TRACOE cleaning brushes with wool tip
• 04035324012190 - TRACOE® care: 2025-05-01 TRACOE cleaning brushes with wool tip
• 04035324012220 - TRACOE® care: 2025-05-01 TRACOE cleaning brushes for flexible tracheostomy tubes
• 04035324012237 - TRACOE® care: 2025-05-01 TRACOE cleaning brushes for flexible tracheostomy tubes
• 04035324012244 - TRACOE® care: 2025-05-01 TRACOE cleaning brushes for flexible tracheostomy tubes
• 04035324012251 - TRACOE® care: 2025-05-01 TRACOE cleaning brushes for flexible tracheostomy tubes
• 04035324014927 - TRACOE® care: 2025-05-01 Neck Strap - 10 units