FDA.reportPublic FDA data

Bongo Rx

Primary DI
10833224005134
Brand
Bongo Rx
Company
AirAvant Medical
Model
BNG513
Catalog number
BNG513
Device description
Bongo Rx - MD - 1 Pack
Published
2019-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep ApneaDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180619000BongoInnomed Healthscience, Inc.2018-08-16OHP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50833224005132PackageGS132In Commercial Distribution
10833224005134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5083322400513250833224005132
1083322400513410833224005134

GMDN Terms#

Term, Definition table
TermDefinition
Nasal dilatorA 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.

Contacts#

Phone, Email table
PhoneEmail
888-925-2526info@airavant.com

Regulatory Flags#

DUNS number
115178777
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10833224005011Bongo RxBNG501BNG5012024-10-21
10833224005110Bongo RxBNG511BNG5112024-10-21
50833224005019Bongo RxBNG501BNG5012024-10-21
50833224005118Bongo RxBNG511BNG5112024-10-21
10833224005004Bongo RxBNG500BNG5002019-04-10
10833224005028Bongo RxBNG502BNG5022019-04-10
10833224005035Bongo RxBNG503BNG5032019-04-10
10833224005042Bongo RxBNG504BNG5042019-04-10
10833224005059Bongo RxBNG505BNG5052019-04-10
10833224005127Bongo RxBNG512BNG5122019-04-10
10833224005141Bongo RxBNG514BNG5142019-04-10
10833224005158Bongo RxBNG515BNG5152019-04-10
50833224005002Bongo RxBNG500BNG5002019-04-10
50833224005026Bongo RxBNG502BNG5022019-04-10
50833224005033Bongo RxBNG503BNG5032019-04-10
50833224005040Bongo RxBNG504BNG5042019-04-10
50833224005057Bongo RxBNG505BNG5052019-04-10
50833224005125Bongo RxBNG512BNG5122019-04-10
50833224005132Bongo RxBNG513BNG5132019-04-10
50833224005149Bongo RxBNG514BNG5142019-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10833224005011Bongo RxAirAvant MedicalOHP2024-10-21
10833224005110Bongo RxAirAvant MedicalOHP2024-10-21
50833224005019Bongo RxAirAvant MedicalOHP2024-10-21
50833224005118Bongo RxAirAvant MedicalOHP2024-10-21
10833224005004Bongo RxAirAvant MedicalOHP2019-04-10
10833224005028Bongo RxAirAvant MedicalOHP2019-04-10
10833224005035Bongo RxAirAvant MedicalOHP2019-04-10
10833224005042Bongo RxAirAvant MedicalOHP2019-04-10
10833224005059Bongo RxAirAvant MedicalOHP2019-04-10
10833224005127Bongo RxAirAvant MedicalOHP2019-04-10
10833224005141Bongo RxAirAvant MedicalOHP2019-04-10
10833224005158Bongo RxAirAvant MedicalOHP2019-04-10
50833224005002Bongo RxAirAvant MedicalOHP2019-04-10
50833224005026Bongo RxAirAvant MedicalOHP2019-04-10
50833224005033Bongo RxAirAvant MedicalOHP2019-04-10
50833224005040Bongo RxAirAvant MedicalOHP2019-04-10
50833224005057Bongo RxAirAvant MedicalOHP2019-04-10
50833224005125Bongo RxAirAvant MedicalOHP2019-04-10
50833224005132Bongo RxAirAvant MedicalOHP2019-04-10
50833224005149Bongo RxAirAvant MedicalOHP2019-04-10
50833224005156Bongo RxAirAvant MedicalOHP2019-04-10
00868020000208Provent Sleep TherapyPROVENT SLEEP THERAPY, LLCOHP2017-08-25
00868020000215Provent Sleep TherapyPROVENT SLEEP THERAPY, LLCOHP2017-08-25