TRACOE® technic

Basic Information

• Brand Name: TRACOE® technic
• Primary DI: 04035324019496
• Version / Model: REF 730
• Company Name: Tracoe medical GmbH
• Labeler DUNS: 319414785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-23
• Public Version: 4
• Public Version Date: 2019-03-21
• Public Version Status: Update
• Public Device Record Key: fa0f9bc6-4943-4d58-ae7f-9f152280d19c

Device Description

TRACOE smart Cuff Manager

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 Unsafe
• 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
BSK	Cuff, tracheal tube, inflatable	Anesthesiology	868.5750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35401	Endotracheal tube cuff inflator	A manually-powered device designed to instill air into the cuff of an in situ endotracheal (ET)/endobronchial tube. The inflator typically includes a manually-operated rubber bulb for the delivery of ambient air into the cuff, and a pressure gauge or manometer that displays the pressure within the cuff to help prevent the development of excessive pressure which may cause trauma to the trachea. The purpose of the cuff is to provide an adequate seal for positive pressure ventilation and to prevent aspirated secretions from passing into the lungs. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035324019496	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152865	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Maintains cuff-pressure between 20 - 30 cmH2O

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The product must be stored in a cool, dry place, protected from sunlight and extreme cold (10°C to 30°C).