Bongo Rx BNG504

GUDID 50833224005040

Bongo Rx - LG - 4 Pack

AirAvant Medical

Nasal dilator
Primary Device ID50833224005040
NIH Device Record Key65c851f3-0b84-40cf-9daa-051f517f4916
Commercial Distribution StatusIn Commercial Distribution
Brand NameBongo Rx
Version Model NumberBNG504
Catalog NumberBNG504
Company DUNS115178777
Company NameAirAvant Medical
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-925-2526
Emailinfo@airavant.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100833224005045 [Unit of Use]
GS110833224005042 [Primary]
GS150833224005040 [Package]
Contains: 10833224005042
Package: Master Carton [32 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-18
Device Publish Date2019-04-10

On-Brand Devices [Bongo Rx]

50833224005156Bongo Rx - XL - 1 Pack
50833224005149Bongo Rx - LG - 1 Pack
50833224005132Bongo Rx - MD - 1 Pack
50833224005125Bongo Rx - SM - 1 Pack
50833224005057Bongo Rx - XL - 4 Pack
50833224005040Bongo Rx - LG - 4 Pack
50833224005033Bongo Rx - MD - 4 Pack
50833224005026Bongo Rx - SM - 4 Pack
50833224005002Bongo Rx - All Sizes Kit (includes 1 each of sizes SM, MD, LG, and XL)

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