RUSCH

Basic Information

• Brand Name: RUSCH
• Primary DI: 04026704005529
• Version / Model: IPN040992
• Catalog Number: 104004-000055
• 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: 3
• Public Version Date: 2019-06-03
• Public Version Status: Update
• Public Device Record Key: 0774fcae-085c-4e4b-80c7-92518ae7936a

Device Description

Armoured tracheal tube, cuffed

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: 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: Yes
• 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
46569	Reinforced endotracheal tube, single-use	An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. It is wire reinforced to prevent kinking during patient movement and may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) have a built-in pilot balloon. It is typically made of plastic or rubber and is available in various diameters and 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	44026704005527	GS1	Carton	98	Not in Commercial Distribution	2018-03-21
Package	24026704005523	GS1	Box	2	Not in Commercial Distribution	2018-03-21
Primary	04026704005529	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K955495	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	5.5	Millimeter
Device Size Text, specify			5.5
Outer Diameter	8.3	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight; Keep dry