TRACOE® twist plus

GUDID 04035324018420

TRACOE twist plus Tracheostomy Tube, Double Fenestrated with Low Pressure Cuff, with atraumatic insertion system

Tracoe medical GmbH

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

• Primary Device ID: 04035324018420
• NIH Device Record Key: add095d8-ef8a-4b6d-b797-6cb081bc6cde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACOE® twist plus
• Version Model Number: REF 312-08-P
• 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

Device Dimensions

• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035324018420 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2025-04-10
• Device Publish Date: 2015-10-18

On-Brand Devices [TRACOE® twist plus]

• 04035324028009: Spare Inner Cannulas, with 15 mm Connector, 30 units
• 04035324027996: Spare Inner Cannulas, with 15 mm Connector, 30 units
• 04035324027989: Spare Inner Cannulas, with 15 mm Connector, 30 units
• 04035324019236: TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
• 04035324019229: TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
• 04035324019199: TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
• 04035324019175: TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
• 04035324018437: TRACOE twist plus Tracheostomy Tube, Double Fenestrated with Low Pressure Cuff, with atraumatic
• 04035324018420: TRACOE twist plus Tracheostomy Tube, Double Fenestrated with Low Pressure Cuff, with atraumatic
• 04035324018390: TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff, with atraumatic insertion system
• 04035324018383: TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff, with atraumatic insertion system
• 04035324018376: TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff, with atraumatic insertion system
• 04035324018369: TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff, with atraumatic insertion system