TRACOE® modular

Basic Information

• Brand Name: TRACOE® modular
• Primary DI: 04035324012930
• Version / Model: REF 650-TO
• 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: 2018-08-23
• Public Version Status: Update
• Public Device Record Key: e928a6b9-79bc-4ef7-82e9-501215d717f3

Device Description

TRACOE phon assist I with Oxygen Supply Port

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
36071	Tracheostomy tube speech valve	A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035324012930	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K043160	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Fits on 15 mm connector

Storage Conditions

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