TRACOE® twist

GUDID 04035324027958

Spare Inner Cannulas, with 15 mm Connector, 30 units

Tracoe medical GmbH

Tracheostomy tube, non-reinforced, non-customized, single-use

• Primary Device ID: 04035324027958
• NIH Device Record Key: 9baf8f62-0462-4a5f-8502-eb02cde37f91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACOE® twist
• Version Model Number: REF 501-07-XXX
• 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: 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
• 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
• 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
• 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

• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Special Storage Condition, Specify: Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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 40 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035324027958 [Primary]
GS1	05701780327930 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961449

FDA Product Code

• JOH: Tube tracheostomy and tube cuff

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: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [TRACOE® twist]

• 04035324027972: Spare Inner Cannulas, with 15 mm Connector, 30 units
• 04035324027965: Spare Inner Cannulas, with 15 mm Connector, 30 units
• 04035324027958: Spare Inner Cannulas, with 15 mm Connector, 30 units
• 04035324027866: Spare Inner Cannulas, with 15 mm Connector, 30 units
• 04035324058617: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324058419: Inner Cannulas, Fenestrated, with Grooved Low Profile Connector (light blue), 3 units
• 04035324056910: Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
• 04035324056811: Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
• 04035324056712: Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
• 04035324056514: Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
• 04035324056415: Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
• 04035324056316: Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
• 04035324049110: Inner Cannulas, Fenestrated, with Integrated Speaking Valve (light blue), 2 units
• 04035324040513: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324040414: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324040216: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324039517: Inner Cannulas, Fenestrated, with Grooved Low Profile Connector (light blue), 3 units
• 04035324039319: Inner Cannulas, Fenestrated, with Grooved Low Profile Connector (light blue), 3 units
• 04035324039111: Inner Cannulas, Fenestrated, with Grooved Low Profile Connector (light blue), 3 units
• 04035324038718: Inner Cannulas, Fenestrated, with Grooved Low Profile Connector (light blue), 3 units
• 04035324037315: Inner Cannulas, Fenestrated, with Integrated Speaking Valve (light blue), 2 units
• 04035324037117: Inner Cannulas, Fenestrated, with Integrated Speaking Valve (light blue), 2 units
• 04035324036912: Inner Cannulas, Fenestrated, with Integrated Speaking Valve (light blue), 2 units
• 04035324035816: Laryngectomy Tube
• 04035324035717: Laryngectomy Tube
• 04035324035618: Laryngectomy Tube
• 04035324035410: Laryngectomy Tube
• 04035324027835: Tracheostomy Tube, Fenestrated, with Low Pressure Cuff and optimated Subglottic Suction Line (
• 04035324016891: Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line, with atraumatic insertion
• 04035324016877: Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line, with atraumatic insertion
• 04035324015207: Tracheostomy Tube, Fenestrated, with Low Pressure Cuff, with atraumatic insertion system
• 04035324015191: Tracheostomy Tube, Fenestrated, with Low Pressure Cuff, with atraumatic insertion system
• 04035324015184: Tracheostomy Tube, Fenestrated, with Low Pressure Cuff, with atraumatic insertion system
• 04035324015177: Tracheostomy Tube with Low Pressure Cuff, with atraumatic insertion system
• 04035324015160: Tracheostomy Tube with Low Pressure Cuff, with atraumatic insertion system
• 04035324015153: Tracheostomy Tube with Low Pressure Cuff, with atraumatic insertion system
• 04035324011469: Inner Cannulas, Fenestrated, with Integrated Speaking Valve (light blue), 2 units