15mm Gas Sample Adaptor Kit

Primary DI
B882900071
Brand
15mm Gas Sample Adaptor Kit
Company
Beyond Air, Inc.
Model
90007
Device description
90007 is a kit containing two off-the-shelf components: - 1: (61920) 15M-15F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 15mm-diameter breathing circuit.
Published
2022-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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
B882900071PackageHIBCC10In Commercial Distribution
B882900072PackageHIBCC12In Commercial Distribution
B882900070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nitric oxide delivery system, secondaryAn assembly of devices dedicated to the short-term delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of patients for the treatment of severe respiratory failure, particularly when a primary delivery system cannot be used (functions as a backup system). It typically includes a computerized main unit that delivers NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system and which also monitors this gaseous mixture, and tubing.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080243711
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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
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