Mallinckrodt

Basic Information

• Brand Name: Mallinckrodt
• Primary DI: 20884521105567
• Version / Model: 5-18441
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-28
• Public Version: 7
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: 74e83490-edb2-4d3a-ac5a-9d99e2c9b875

Device Description

Esophageal Tracheal Airway, Rollup Kit,Double Lumen,140 mL. Syringe; 20 mL. Syringe; Suction Catheter; Elbow; Caution: Lay flat and maintain shape of distal curve when packing Esophageal Tracheal Airway with other items.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAO	AIRWAY, ESOPHAGEAL (OBTURATOR)	Anesthesiology	868.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42420	Oesophageal-obturating/tracheal airway, single-use	A two-lumen, semiflexible, single-use tube inserted blindly through the mouth into the oesophagus or trachea to maintain airway patency while obturating the oesophagus, typically during emergencies to facilitate breathing/resuscitation. The oesophageal-obturating lumen has a blocked distal end and perforations at the pharyngeal level. A large oropharyngeal balloon seals mouth and nose; a distal cuff seals either the oesophagus or the trachea. Ventilation starts via the oesophageal tube, if the tube is in the oesophagus air enters the pharynx via the perforations; when the tube is in the trachea the ventilation is performed directly through the tracheal tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884521105560	GS1	CASE	4	In Commercial Distribution
Primary	20884521105567	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K875226	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	41	French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 90 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Do not expose to UV