TRACOE silcosoft REF 373-3.0-C45

GUDID 04035324032297

Tracheostomy Tube for Children

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

• Primary Device ID: 04035324032297
• NIH Device Record Key: 89a70705-2141-4600-8104-0c874d5ab7ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACOE silcosoft
• Version Model Number: REF 373-3.0-C45
• Catalog Number: REF 373-3.0-C45
• Company DUNS: 319414785
• Company Name: Tracoe medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035324032297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172720

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: 2021-05-03
• Device Publish Date: 2021-04-23

On-Brand Devices [TRACOE silcosoft]

• 04035324031849: Tracheostomy Tube for Children
• 04035324032297: Tracheostomy Tube for Children
• 04035324032334: Tracheostomy Tube for Children
• 04035324032228: Tracheostomy Tube for Children