FDA.reportPublic FDA data

Bongo Rx

Primary DI
50833224005019
Brand
Bongo Rx
Company
AirAvant Medical
Model
BNG501
Catalog number
BNG501
Device description
Bongo Rx - XS - 4 Pack
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
50833224005019PackageGS132In Commercial Distribution
10833224005011PrimaryGS10
00833224005014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5083322400501950833224005019
1083322400501110833224005011
00833224005014008332240050148332240050140833224005014

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
115178777
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10833224005011Bongo RxBNG501BNG5012024-10-21
10833224005110Bongo RxBNG511BNG5112024-10-21
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
10833224005134Bongo RxBNG513BNG5132019-04-10
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
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
10833224005134Bongo 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