FDA.reportPublic FDA data

Sample Line with Nafion Tube Kit

Primary DI
B882900310
Brand
Sample Line with Nafion Tube Kit
Company
Beyond Air, Inc.
Model
90031
Device description
The Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH.
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
B882900311PackageHIBCC10In Commercial Distribution
B882900312PackageHIBCC12In Commercial Distribution
B882900310PrimaryHIBCC0

Sterilization Methods#

Method table
Method

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

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
B882900160Luer Elbow 7.6mm Port Kit900162022-08-04
B88290017022mm Gas Sample Adaptor Kit900172022-08-04
B882900020LungFit PH900022022-08-04
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
B882900160Luer Elbow 7.6mm Port 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