Bongo Rx

FDA UDI

Class II (US FDA UDI)

by AirAvant Medical

Identity

Trade Name: Bongo Rx FDA UDI
Generic Name: Nasal dilator FDA UDI
Device Name: Bongo Rx - XS - 1 Pack FDA UDI
Model / Reference: BNG511 FDA UDI
Description: Bongo Rx - XS - 1 Pack FDA UDI

Identifiers

Catalog Number: BNG511 FDA UDI
Primary DI / UDI-DI: 10833224005110 FDA UDI
510(k) Number: K180619 FDA UDI
FDA Product Code: OHP FDA UDI
GMDN Term: Nasal dilator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Nasal dilator

Bongo Rx by AirAvant Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Provent Sleep Therapy — PROVENT SLEEP THERAPY, LLC · Class II
Bioseal Inc. — BIOSEAL · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Bioseal Inc. — BIOSEAL · Class I

Cleared under the same submission

K180619 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: AirAvant Medical

Sources (1)

FDA UDI 37399cc0-d813-4227-b404-ad217e7f59a2 36 fields · synced May 31, 2026