TRACOE® twist

GUDID 04035324027965

Spare Inner Cannulas, with 15 mm Connector, 30 units

Tracoe medical GmbH

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

• Primary Device ID: 04035324027965
• NIH Device Record Key: 401fe955-0738-40cd-bfd5-0dc605b6eb54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACOE® twist
• Version Model Number: REF 501-06-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

Device Dimensions

• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035324027965 [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: 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]

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• 04035324027866: Spare Inner Cannulas, with 15 mm Connector, 30 units