FDA.reportPublic FDA data

Luer Elbow 7.6mm Port Kit

Primary DI
B882900160
Brand
Luer Elbow 7.6mm Port Kit
Company
Beyond Air, Inc.
Model
90016
Device description
The Luer elbow is a component to the gas sampling port which fits on a breathing circuit.
Published
2022-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QTBNitric Oxide Generator And Delivery System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTBNitric Oxide Generator And Delivery SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200044000LungFit PHBeyond Air, Inc.2022-06-28QTB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B882900161PackageHIBCC10In Commercial Distribution
B882900162PackageHIBCC12In Commercial Distribution
B882900160PrimaryHIBCC0

Contacts#

Phone, Email table
PhoneEmail
1-855-586-4359xxx@xx.xxx

Regulatory Flags#

DUNS number
080243711
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B882800130LungFit PH Breathing Circuit 1 Kit800132025-05-19
B882800120LungFit PH Breathing Circuit 2 Kit800122025-02-13
B88280011122M-6mm Connector - Multipack800112023-08-16
B882900050LungFit PH Bagging Kit900052022-08-04
B88290006010mm Gas Sample Adaptor900062022-08-04
B88290007015mm Gas Sample Adaptor Kit900072022-08-04
B882900080LungFit PH NO2 Filter900082022-08-04
B882900090LungFit PH NO2 Bagging Filter900092022-08-04
B882900140LungFit PH NDM Assembly Kit900142022-08-04
B882900150LungFit PH Verification Kit900152022-08-04
B88290017022mm Gas Sample Adaptor Kit900172022-08-04
B882900020LungFit PH900022022-08-04
B882900310Sample Line with Nafion Tube Kit900312022-08-04
B88280011222M-6mm Connector - Multipack800112023-08-16
B882900051LungFit PH Bagging Kit900052022-08-04
B88290006110mm Gas Sample Adaptor900062022-08-04
B88290007115mm Gas Sample Adaptor Kit900072022-08-04
B882900081LungFit PH NO2 Filter900082022-08-04
B882900091LungFit PH NO2 Bagging Filter900092022-08-04
B882900141LungFit PH NDM Assembly Kit900142022-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B882800130LungFit PH Breathing Circuit 1 KitBeyond Air, Inc.QTB2025-05-19
B882800120LungFit PH Breathing Circuit 2 KitBeyond Air, Inc.QTB2025-02-13
B88280011122M-6mm Connector - MultipackBeyond Air, Inc.QTB2023-08-16
B88280011222M-6mm Connector - MultipackBeyond Air, Inc.QTB2023-08-16
B882900050LungFit PH Bagging KitBeyond Air, Inc.QTB2022-08-04
B88290006010mm Gas Sample AdaptorBeyond Air, Inc.QTB2022-08-04
B88290007015mm Gas Sample Adaptor KitBeyond Air, Inc.QTB2022-08-04
B882900080LungFit PH NO2 FilterBeyond Air, Inc.QTB2022-08-04
B882900090LungFit PH NO2 Bagging FilterBeyond Air, Inc.QTB2022-08-04
B882900140LungFit PH NDM Assembly KitBeyond Air, Inc.QTB2022-08-04
B882900150LungFit PH Verification KitBeyond Air, Inc.QTB2022-08-04
B88290017022mm Gas Sample Adaptor KitBeyond Air, Inc.QTB2022-08-04
B882900020LungFit PHBeyond Air, Inc.QTB2022-08-04
B882900051LungFit PH Bagging KitBeyond Air, Inc.QTB2022-08-04
B88290006110mm Gas Sample AdaptorBeyond Air, Inc.QTB2022-08-04
B88290007115mm Gas Sample Adaptor KitBeyond Air, Inc.QTB2022-08-04
B882900081LungFit PH NO2 FilterBeyond Air, Inc.QTB2022-08-04
B882900091LungFit PH NO2 Bagging FilterBeyond Air, Inc.QTB2022-08-04
B882900141LungFit PH NDM Assembly KitBeyond Air, Inc.QTB2022-08-04
B882900151LungFit PH Verification KitBeyond Air, Inc.QTB2022-08-04
B882900161Luer Elbow 7.6mm Port KitBeyond Air, Inc.QTB2022-08-04
B88290017122mm Gas Sample Adaptor KitBeyond Air, Inc.QTB2022-08-04
B882900310Sample Line with Nafion Tube KitBeyond Air, Inc.QTB2022-08-04