HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 14026704617064
• Version / Model: IPN048958
• Catalog Number: 5-12613
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-20
• Public Version: 17
• Public Version Date: 2024-02-13
• Public Version Status: Update
• Public Device Record Key: 078d646e-5fae-4e48-91e2-3d08dd775c78

Device Description

ET TUBE, CUFFED, SPIRAL-FLEX 6.5

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: MR Unsafe
• 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	44026704617065	GS1	Case	20	In Commercial Distribution
Package	34026704617068	GS1	Box	5	In Commercial Distribution
Primary	14026704617064	GS1
Previous	04026704397396	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K844296	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Cuffed Reinforced Tracheal Tube, Oral/Nasal

Storage Conditions

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