FDA.reportPublic FDA data

NOxBOXi

Primary DI
05060541640085
Brand
NOxBOXi
Company
NOXBOX LTD
Model
NOXKIT-HFJV
Catalog number
NXBNOXKIT-HFJV
Device description
Single use connections kit for Bunnell Jet ventilator
Published
2018-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
MRNApparatus, Nitric Oxide Delivery
MROApparatus, Nitric Oxide, Backup Delivery
MRPAnalyzer, Nitric Oxide
MRQAnalyzer, Nitrogen Dioxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2
MRNApparatus, Nitric Oxide DeliveryAnesthesiology2
MROApparatus, Nitric Oxide, Backup DeliveryAnesthesiology2
MRPAnalyzer, Nitric OxideAnesthesiology2
MRQAnalyzer, Nitrogen DioxideAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171696000NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc.2018-10-02MRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060541640082PackageGS110In Commercial Distribution
25060541640089PackageGS14In Commercial Distribution
05060541640085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506054164008215060541640082
2506054164008925060541640089
05060541640085050605416400855060541640085

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure800 millibar1200 millibar
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure800 millibar1200 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-833-669-8368NoxiventUS@Praxair.com

Regulatory Flags#

DUNS number
220841986
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060541640078NOxBOXiNOXBOX-I TESTNXBNOXBOXI-TEST2018-11-05
25060541640072NOxBOXiNOXBOX-I TESTNXBNOXBOXI-TEST2018-11-05
15060541640112NOxBOXiFXS555NXBFXS5552018-11-05
15060541640129NOxBOXiFIL063NXBFIL0632018-11-05
15060541640136NOxBOXiFIL064NXBFIL0642018-11-05
15060541640143NOxBOXiCON158NXBCON1582018-11-05
05060541640030NOxBOXiNOXKIT-2-22NXBNOXKIT-2-222018-11-05
05060541640047NOxBOXiNOXKIT-2-15NXBNOXKIT-2-152018-11-05
05060541640054NOxBOXiNOXKIT-1-10NXBNOXKIT-1-102018-11-05
05060541640061NOxBOXiNOXKIT-2-12NXBNOXKIT-2-122018-11-05
95060541640118NOxBOXiFXS555NXBFXS5552018-11-05
95060541640125NOxBOXiFIL063NXBFIL0632018-11-05
95060541640132NOxBOXiFIL064NXBFIL0642018-11-05
95060541640149NOxBOXiCON158NXBCON1582018-11-05
15060541640167NOxBOXiNOXKIT-EMERNXBNOXKIT-EMER2018-11-05
05060541640016NOxBOXiNOXBOX-INXBNOXBOX-I2018-11-05
05060541640023NOxBOXiNOXDC-INXBNOXDC-I2018-11-05
25060541640034NOxBOXiNOXKIT-2-22NXBNOXKIT-2-222018-11-05
25060541640041NOxBOXiNOXKIT-2-15NXBNOXKIT-2-152018-11-05
25060541640058NOxBOXiNOXKIT-1-10NXBNOXKIT-1-102018-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561297AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561303AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561624AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561631AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561655AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561662AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561679AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561686AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561693AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
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