SH 77-5 Oropharyngeal Airway

Basic Information

• Brand Name: SH 77-5 Oropharyngeal Airway
• Primary DI: M996SH7750
• Version / Model: SH 77-5
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-16
• Public Version: 1
• Public Version Date: 2019-03-25
• Public Version Status: New
• Public Device Record Key: ec2a3726-4ad2-46d9-bbe7-11f4df0ebb65

Device Description

Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 80 mm.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
42424	Oropharyngeal airway, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M996SH7755	HIBCC	Polybag	50	In Commercial Distribution
Primary	M996SH7750	HIBCC
Package	M996SH7752	HIBCC	Polybag	10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	80	Millimeter