Bongo Rx

Basic Information

• Brand Name: Bongo Rx
• Primary DI: 10833224005035
• Version / Model: BNG503
• Catalog Number: BNG503
• Company Name: AirAvant Medical
• Labeler DUNS: 115178777
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2019-04-10
• Public Version: 1
• Public Version Date: 2019-04-18
• Public Version Status: New
• Public Device Record Key: b55bc178-abab-4a9a-bcc5-fd170edd2d47

Device Description

Bongo Rx - MD - 4 Pack

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: No
• 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
OHP	Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11260	Nasal dilator	A surgical instrument intended to dilate nasal structures/passages during ear/nose/throat (ENT) procedures. It typically consists of a slender and cylindrical body, hollow or solid, made of metal or plastic and available in a variety of sizes and flexibilities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50833224005033	GS1	Master Carton	32	In Commercial Distribution
Primary	10833224005035	GS1
Unit of Use	00833224005038	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180619	000