Endure

Basic Information

• Brand Name: Endure
• Primary DI: B531OA1220
• Version / Model: OA1221217
• Catalog Number: OA122
• Company Name: ENDURE INDUSTRIES
• Labeler DUNS: 066087031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 983fc2c8-7bc1-43eb-8d5c-90a6ab936881

Device Description

Oropharyngeal Airway, Size 120 mm, Non-Sterile

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: 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: Yes
• 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
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	B531OA1222	HIBCC	Carton	10	In Commercial Distribution
Package	B531OA1221	HIBCC	Box	15	In Commercial Distribution
Primary	B531OA1220	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	120	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 49 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 0 – 49 Degrees Celsius