TRACOE® comfort

GUDID 04035324032259

Spare-tube, with 22 mm adapter

Tracoe medical GmbH

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

• Primary Device ID: 04035324032259
• NIH Device Record Key: 114d9a1f-7243-4f62-acf8-fc7ffbb89299
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACOE® comfort
• Version Model Number: REF 888-107-09IK
• 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

Device Dimensions

• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 Millimeter
• Lumen/Inner Diameter: 5.8 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035324032259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K781729

FDA Product Code

• BTO: Tube, tracheostomy (w/wo connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-23
• Device Publish Date: 2020-10-15

On-Brand Devices [TRACOE® comfort]

• 04035324031856: Inner Cannula (substitute), extra long with speaking Valve, clamp below, variant
• 04035324032204: Additional Extra-Long Inner Cannula, Fenestrated, with Speaking Valve, with additional oxygen su
• 04035324032198: Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp abov
• 04035324032235: Extra-Long spare inner tube, Fenestrated, with speaking valve variation
• 04035324032259: Spare-tube, with 22 mm adapter
• 04035324032273: Spare inner tube, with speaking valve type A (silver valve holder), with oxygen supply port
• 04035324032242: Spare inner tube, with speaking valve type A (silver valve holder), hook below
• 04035324032280: Spare inner tube, with speaking valve type B, hook above
• 04035324032266: comfort variant, spare inner tube with speaking valve type B
• 04035324032303: comfort variant, spare inner tube with speaking valve type B, hook top