TRACOE® modular

GUDID 04035324011704

TRACOE humid assist III, 50 units

Tracoe medical GmbH

Heat/moisture exchanger, single-use

• Primary Device ID: 04035324011704
• NIH Device Record Key: 7e11e168-d1cf-4c7a-9ddc-e9d80c2c291f
• Commercial Distribution Discontinuation: 2025-03-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TRACOE® modular
• Version Model Number: REF 645
• Company DUNS: 319414785
• Company Name: Tracoe medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container
• Special Storage Condition, Specify: Between 0 and 0 *Unused valves should always be kept in a clean, dry condition in a clean ventilated container

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035324011704 [Primary]

FDA Product Code

• BYD: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

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: 2025-04-29
• Device Publish Date: 2015-10-18

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• 04035324011704: TRACOE humid assist III, 50 units