TRACOE® twist

Basic Information

• Brand Name: TRACOE® twist
• Primary DI: 04035324015191
• Version / Model: REF 302-08-P
• Company Name: Tracoe medical GmbH
• Labeler DUNS: 319414785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-18
• Public Version: 4
• Public Version Date: 2020-06-05
• Public Version Status: Update
• Public Device Record Key: 3865977e-379f-461c-ab17-ba1299096d7d

Device Description

Tracheostomy Tube, Fenestrated, with Low Pressure Cuff, with atraumatic insertion system

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOH	Tube tracheostomy and tube cuff	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35404	Tracheostomy tube, non-reinforced, non-customized, single-use	A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035324015191	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K961449	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	8.0	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.