TRACOE silcosoft

Basic Information

• Brand Name: TRACOE silcosoft
• Primary DI: 04035324029976
• Version / Model: REF 371-3.5-C65
• Catalog Number: REF 371-3.5-C65
• Company Name: Tracoe medical GmbH
• Labeler DUNS: 319414785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-24
• Public Version: 3
• Public Version Date: 2020-06-05
• Public Version Status: Update
• Public Device Record Key: 8f8f4e78-64f2-4537-9415-402fd34d541f

Device Description

Tracheostomy Tube for Children

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: MR Conditional
• 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	04035324029976	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172720	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	3.5	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius