FDA.reportPublic FDA data

AeroNOx 2.0 Nitric Oxide Delivery Device

Primary DI
00865648000337
Brand
AeroNOx 2.0 Nitric Oxide Delivery Device
Company
INTERNATIONAL BIOMEDICAL, LTD.
Model
AeroNOx 2.0
Catalog number
731-9159
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MRNApparatus, Nitric Oxide Delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRNApparatus, Nitric Oxide DeliveryAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193481000AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemInternational Biomedical2020-03-10MRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865648000337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865648000337008656480003378656480003370865648000337

GMDN Terms#

Term, Definition table
TermDefinition
Nitric oxide delivery unit, system-basedA mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
073179368
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018561099Wee Sight Transilluminator 9898056037612023-06-20
00865648000306Aviator Transport IncubatorAviator2023-06-20
00865648000320Voyager Infant Transport IncubatorVoyager2023-06-20
00868406000099185A+ Infant Incubator185A+2023-06-20
00850018561020NxtGen Infant Transport IncubatorNxtGen732-00002023-04-07
00850018561013NxtGen Infant Transport IncubatorNxtGen738-21342022-10-27
00868406000006Aviator Transport IncubatorAviator2016-09-27
00868406000013A750i Infant IncubatorA750i2016-09-27
00868406000020Voyager Infant Transport IncubatorVoyager2016-09-27
00868406000037185A+ Infant Incubator185A+2016-09-27
00850018561273WeeSpecs Infant Eye ProtectionWeeSpecs2023-06-21
00850018561204LC Accu-Bar Temperature Trend Indicator9898056230012023-06-20
00850018561594Infant Heel Warmer122312232023-06-20
00850018561600Infant Heel Snuggler99047990472023-06-20
00850018561648NeoPod T, Neonatal Transport Humidification System940094002023-06-20
00865648000313NuBorne Infant WarmerWarmer2023-06-20
00865648000344Puffin Lite Infant ResuscitatorPuffin2023-06-20
00850018561587Infa-Therm Mattress101510152023-04-07
00868406000051LifeBorne Puffin Infant Resuscitator738-1099738-10992016-09-26
00868406000068AeroNOx Nitric Oxide Delivery DeviceAeroNOx731-91482016-09-26

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