TRACOE® mini

GUDID 04035324028047

Tracheostomy Tube for Neonates

Tracoe medical GmbH

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

• Primary Device ID: 04035324028047
• NIH Device Record Key: 5cced701-010d-42df-bee8-b9e7b30d7706
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACOE® mini
• Version Model Number: REF 888-350-3.5-C
• 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

Device Dimensions

• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035324028047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K893866

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-10-16
• Device Publish Date: 2018-10-22

On-Brand Devices [TRACOE® mini]

• 04035324032372: Tracheostomy Tube for Children
• 04035324032365: Tracheostomy Tube for Children
• 04035324028702: Tracheostomy Tube for Neonates
• 04035324028696: Tracheostomy Tube for Neonates
• 04035324028689: Tracheostomy Tube for Neonates, product variation
• 04035324028047: Tracheostomy Tube for Neonates