TRACOE® technic

Basic Information

• Brand Name: TRACOE® technic
• Primary DI: 04035324046317
• Version / Model: REF 702
• Company Name: Tracoe medical GmbH
• Labeler DUNS: 319414785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-19
• Public Version: 1
• Public Version Date: 2019-09-27
• Public Version Status: New
• Public Device Record Key: 0ccbf3b2-cf6b-4214-a6de-0973775c0b11

Device Description

TRACOE Connection tube

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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
BSK	Cuff, tracheal tube, inflatable	Anesthesiology	868.5750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62966	Artificial airway cuff inflation tubing	A length of flexible tube designed to connect cuff inflation devices to deliver air during inflation of the cuff of an endotracheal (ET)/ tracheostomy tube. It typically includes connectors at each end. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035324046317	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152778	000

Device Sizes

Type	Value	Unit	Text
Length	1	Meter