FDA.reportPublic FDA data

NOxBOXi

Primary DI
15060541640136
Brand
NOxBOXi
Company
NOXBOX LTD
Model
FIL064
Catalog number
NXBFIL064
Device description
Single use 50mm Nebuliser filter
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
95060541640132PackageGS1999999999In Commercial Distribution
15060541640136PrimaryGS10
05060541640139Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
9506054164013295060541640132
1506054164013615060541640136
05060541640139050605416401395060541640139

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
50
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
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
05060541640085NOxBOXiNOXKIT-HFJVNXBNOXKIT-HFJV2018-11-05
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

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Primary DI, Brand, Company table
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00817770025856MaxBlend2MAXTEC, LLCCCL2024-08-14
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00810055280100INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280148INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280155INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00850046301148NOxBOXi NOxFLOWLinde Gas & Equipment Inc.MRP2023-08-30
10190752191235Vital Signs™AirLife Finland OyCCL2023-05-30
00850046301025NOxBOXi NOXKIT 1-10Linde Gas & Equipment Inc.MRP2023-05-01
00850046301049NOxBOXi NOXKIT 2-12Linde Gas & Equipment Inc.MRP2023-05-01
00850046301063NOxBOXi NOXKIT 2-22Linde Gas & Equipment Inc.MRP2023-05-01
00850046301087NOxBOXi NOXKIT 2-15Linde Gas & Equipment Inc.MRP2023-05-01
00850046301100NOxBOXi NOXKIT HFJVLinde Gas & Equipment Inc.MRP2023-05-01
00850046301124NOxBOXi NOXKIT EMERLinde Gas & Equipment Inc.MRP2023-05-01
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCCL2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyCCL2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCCL2023-04-19
00195278524089NAGE Healthcare Finland OyCCL2023-04-19
00850046301001NOxBOXi System-I Test KitLinde Gas & Equipment Inc.MRP2023-02-13
00810055285051INOmaxMallinckrodt Manufacturing LLCMRN2023-02-01
00810055285051INOmaxMallinckrodt Manufacturing LLCMRO2023-02-01
00810055285051INOmaxMallinckrodt Manufacturing LLCMRP2023-02-01
00810055285082INOmaxMallinckrodt Manufacturing LLCMRP2023-02-01
00810055285082INOmaxMallinckrodt Manufacturing LLCMRN2023-02-01