TRACOE twist plus REF 523-09-X

GUDID 04035324018345

Spare Inner Cannulas, with 15 mm Connector, 10 units

Tracoe medical GmbH

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

• Primary Device ID: 04035324018345
• NIH Device Record Key: 6abed345-2979-4ab1-a191-fac69fa0c955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACOE twist plus
• Version Model Number: REF 523-09-X
• Catalog Number: REF 523-09-X
• Company DUNS: 319414785
• Company Name: Tracoe medical GmbH
• Device Count: 10
• 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: false
• 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

Device Dimensions

• Lumen/Inner Diameter: 9 Millimeter
• Lumen/Inner Diameter: 9 Millimeter
• Lumen/Inner Diameter: 9 Millimeter
• Lumen/Inner Diameter: 9 Millimeter
• Lumen/Inner Diameter: 9 Millimeter
• Lumen/Inner Diameter: 9 Millimeter
• Lumen/Inner Diameter: 9 Millimeter
• Lumen/Inner Diameter: 9 Millimeter
• Lumen/Inner Diameter: 9 Millimeter
• Lumen/Inner Diameter: 9 Millimeter

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 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035324018345 [Primary]
GS1	05701780328340 [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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2024-11-29
• Device Publish Date: 2015-10-18

On-Brand Devices [TRACOE twist plus]

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• 04035324019090: TRACOE twist plus Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
• 04035324019083: TRACOE twist plus Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
• 04035324019076: TRACOE twist plus Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
• 04035324018932: TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
• 04035324018925: TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
• 04035324018901: TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
• 04035324018895: TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
• 04035324018352: Spare Inner Cannulas, with 15 mm Connector, 10 units
• 04035324018345: Spare Inner Cannulas, with 15 mm Connector, 10 units
• 04035324018338: Spare Inner Cannulas, with 15 mm Connector, 10 units
• 04035324018321: Spare Inner Cannulas, with 15 mm Connector, 10 units
• 04035324018307: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324018291: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324018284: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324018277: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324018260: Spare Inner Cannulas, with 15 mm Connector, 10 units
• 04035324018253: Spare Inner Cannulas, with 15 mm Connector, 10 units
• 04035324018246: Spare Inner Cannulas, with 15 mm Connector, 10 units
• 04035324018239: Spare Inner Cannulas, with 15 mm Connector, 10 units
• 04035324018222: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324018215: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324018208: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324018192: Spare Inner Cannulas, with 15 mm Connector, 3 units
• 04035324018185: TRACOE twist plus Tracheostomy Tube, Double Fenestrated
• 04035324018178: TRACOE twist plus Tracheostomy Tube, Double Fenestrated
• 04035324018161: TRACOE twist plus Tracheostomy Tube, Double Fenestrated
• 04035324018154: TRACOE twist plus Tracheostomy Tube, Double Fenestrated
• 04035324018147: TRACOE twist plus Tracheostomy Tube
• 04035324018130: TRACOE twist plus Tracheostomy Tube
• 04035324018123: TRACOE twist plus Tracheostomy Tube
• 04035324018109: TRACOE twist plus Tracheostomy Tube
• 04035324018024: TRACOE twist plus Tracheostomy Tube, Double Fenestrated with Low Pressure Cuff
• 04035324018000: TRACOE twist plus Tracheostomy Tube, Double Fenestrated with Low Pressure Cuff
• 04035324017997: TRACOE twist plus Tracheostomy Tube, Double Fenestrated with Low Pressure Cuff
• 04035324017980: TRACOE twist plus Tracheostomy Tube, Double Fenestrated with Low Pressure Cuff
• 04035324017973: TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff
• 04035324017966: TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff
• 04035324017959: TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff
• 04035324017942: TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff