Mallinckrodt

Basic Information

• Brand Name: Mallinckrodt
• Primary DI: 10884521133136
• Version / Model: 8888247064
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-20
• Public Version: 4
• Public Version Date: 2023-03-21
• Public Version Status: Update
• Public Device Record Key: c3d10c05-cec5-4dd8-b17d-45d878befa9c

Device Description

Nasopharyngeal Airway

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: 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
BTQ	AIRWAY, NASOPHARYNGEAL	Anesthesiology	868.5100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42422	Nasopharyngeal airway, single-use	A rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30884521133130	GS1	CASE	10	In Commercial Distribution
Primary	10884521133136	GS1
Package	20884521133133	GS1	PACK_OR_INNER_PACK	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K760125	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Inner Diameter, 8.5, MM; Outer Diameter, 11.3, MM;
Catheter Gauge	34	French