TELEFLEX

Basic Information

• Brand Name: TELEFLEX
• Primary DI: 04026704588343
• Version / Model: IPN044811
• Catalog Number: 5-13014
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 4
• Public Version Date: 2019-10-04
• Public Version Status: Update
• Public Device Record Key: 25a275b7-2588-4a33-ab0f-92a5e43cd243

Device Description

TFX ISIS SUBGLOTTIC SEC. ETT, 7.0

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
BTR	Tube, tracheal (w/wo connector)	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47691	Cuff-suction endotracheal tube	A hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	44026704588341	GS1	Case	10	Not in Commercial Distribution	2019-09-30
Package	24026704588347	GS1	Box	10	Not in Commercial Distribution	2019-09-30
Primary	04026704588343	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091761	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Tracheal Tube, Cuffed with Subglottic Secretion Suction Port
Length	15	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 122 Degrees Fahrenheit