TRACOE® modular

GUDID 04035324057016

modular Stopper for temporary closure of the 22 mm housing, 5 units

Tracoe medical GmbH

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• Primary Device ID: 04035324057016
• NIH Device Record Key: 98461997-3387-4aaf-bf9e-41261050112e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACOE® modular
• Version Model Number: REF 621
• 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: false
• 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

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions
• Special Storage Condition, Specify: Between 0 and 0 *no Special Storage Conditions

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035324057016 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-17

Devices Manufactured by Tracoe medical GmbH

• 04035324057016 - TRACOE® modular: 2023-06-26modular Stopper for temporary closure of the 22 mm housing, 5 units
• 04035324057016 - TRACOE® modular: 2023-06-26 modular Stopper for temporary closure of the 22 mm housing, 5 units
• 04035324060917 - TRACOE® care: 2023-06-26 TRACOE tube clean Cleaning powder
• 04035324061112 - TRACOE® care: 2023-06-26 TRACOE tube clean Cleaning tub
• 04035324027866 - TRACOE® twist: 2023-06-23 Spare Inner Cannulas, with 15 mm Connector, 30 units
• 04035324027958 - TRACOE® twist: 2023-06-23 Spare Inner Cannulas, with 15 mm Connector, 30 units
• 04035324027965 - TRACOE® twist: 2023-06-23 Spare Inner Cannulas, with 15 mm Connector, 30 units
• 04035324027972 - TRACOE® twist: 2023-06-23 Spare Inner Cannulas, with 15 mm Connector, 30 units
• 04035324027989 - TRACOE® twist plus: 2023-06-23 Spare Inner Cannulas, with 15 mm Connector, 30 units