REUSABLE SILICONE LARYNGEAL AIRWAY MASK

Basic Information

• Brand Name: REUSABLE SILICONE LARYNGEAL AIRWAY MASK
• Primary DI: 04716770773155
• Version / Model: LA-77315
• Company Name: BESMED HEALTH BUSINESS CORP.
• Labeler DUNS: 658023775
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-22
• Public Version: 1
• Public Version Date: 2019-07-30
• Public Version Status: New
• Public Device Record Key: e6a4e9ed-cdbd-4c45-9bf9-adcb57981b36

Device Description

REUSABLE SILICONE LARYNGEAL AIRWAY MASK SIZE:1.5; AMBU Code:340150000

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	868.5110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42423	Oropharyngeal airway, reusable	A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04716770773155	GS1