Mallinckrodt

Basic Information

• Brand Name: Mallinckrodt
• Primary DI: 40884522000209
• Version / Model: 86492
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-30
• Public Version: 5
• Public Version Date: 2022-09-23
• Public Version Status: Update
• Public Device Record Key: efa2c517-9b64-4d2d-ac11-b39307a223ef
• Distribution End Date: 2021-04-09

Device Description

Hi-Lo Oral Tracheal Tube,Intermediate, Pre-Cut

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: Yes
• 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
46967	Basic endotracheal tube, single-use	A 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 does not include an antimicrobial agent(s). The device 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) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It 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	60884522000203	GS1	PACK_OR_INNER_PACK	10	Not in Commercial Distribution	2021-04-09
Primary	40884522000209	GS1
Package	50884522000206	GS1	CASE	10	Not in Commercial Distribution	2021-04-09

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K965132	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Inner Diameter, 8.0, MM; Outer Diameter, 10.8, MM;

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not expose to UV;Avoid temperature extremes