FDA.reportPublic FDA data

NOxBOXi System-I Test Kit

Primary DI
00850046301001
Brand
NOxBOXi System-I Test Kit
Company
Linde Gas & Equipment Inc.
Model
1
Device description
NOxBOXi System-I Test Kit for use with the NOxBOXi nitric oxide delivery device.
Published
2023-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRPAnalyzer, Nitric Oxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRPAnalyzer, Nitric OxideAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850046301018PackageGS110In Commercial Distribution
00850046301001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046301018008500463010188500463010180850046301018
00850046301001008500463010018500463010010850046301001

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
042845636
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850046301209NOxBOXi NOXKIT 3-221LGENOXKIT3-222024-01-26
00850046301223NOxBOXi NOXKIT 3-HFJV1LGENOXKIT3-HFJV2024-01-26
00850046301025NOxBOXi NOXKIT 1-101LGENOXKIT-1-102023-05-01
00850046301063NOxBOXi NOXKIT 2-221LGENOXKIT-2-222023-05-01
00850046301087NOxBOXi NOXKIT 2-151LGENOXKIT-2-152023-05-01
00850046301100NOxBOXi NOXKIT HFJV1LGENOXKIT-HFJV2023-05-01
00850046301124NOxBOXi NOXKIT EMER1LGENOXKIT-EMER2023-05-01
00850046301148NOxBOXi NOxFLOW1NXBNOXFLOW-22023-08-30
00850046301155NOxBOXi NOxFLOW1LGENOXFLOW-22023-08-30
00850046301162MediPure Lung Diffusion Mixture12023-08-15
00850046301179MediPure Blood Gas Mixture12023-08-15
00850046301186MediPure Laser Gas Mixture12023-08-15
00850046301193MediPure Calibration Gas Mixtures12023-08-15
00850046301049NOxBOXi NOXKIT 2-121LGENOXKIT-2-122023-05-01
00850046301032NOxBOXi NOXKIT 1-101LGENOXKIT-1-102023-05-01
00850046301056NOxBOXi NOXKIT 2-121LGENOXKIT-2-122023-05-01
00850046301070NOxBOXi NOXKIT 2-221LGENOXKIT-2-222023-05-01
00850046301094NOxBOXi NOXKIT 2-151LGENOXKIT-2-152023-05-01
00850046301117NOxBOXi NOXKIT HFJV1LGENOXKIT-HFJV2023-05-01
00850046301131NOxBOXi NOXKIT EMER1LGENOXKIT-EMER2023-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850046301209NOxBOXi NOXKIT 3-22Linde Gas & Equipment Inc.MRP2024-01-26
00850046301223NOxBOXi NOXKIT 3-HFJVLinde Gas & Equipment Inc.MRP2024-01-26
03760333380671Ulspira TSAirgas Therapeutics, LLCMRP2024-01-02
00850046301148NOxBOXi NOxFLOWLinde Gas & Equipment Inc.MRP2023-08-30
00850046301155NOxBOXi NOxFLOWLinde Gas & Equipment Inc.MRP2023-08-30
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
00850046301032NOxBOXi NOXKIT 1-10Linde Gas & Equipment Inc.MRP2023-05-01
00850046301056NOxBOXi NOXKIT 2-12Linde Gas & Equipment Inc.MRP2023-05-01
00850046301070NOxBOXi NOXKIT 2-22Linde Gas & Equipment Inc.MRP2023-05-01
00850046301094NOxBOXi NOXKIT 2-15Linde Gas & Equipment Inc.MRP2023-05-01
00850046301117NOxBOXi NOXKIT HFJVLinde Gas & Equipment Inc.MRP2023-05-01
00850046301131NOxBOXi NOXKIT EMERLinde Gas & Equipment Inc.MRP2023-05-01
00810055285051INOmaxMallinckrodt Manufacturing LLCMRP2023-02-01
00810055285082INOmaxMallinckrodt Manufacturing LLCMRP2023-02-01
00810055285099INOmaxMallinckrodt Manufacturing LLCMRP2023-02-01
15060541640112NOxBOXiNOXBOX LTDMRP2018-11-05
15060541640129NOxBOXiNOXBOX LTDMRP2018-11-05
15060541640136NOxBOXiNOXBOX LTDMRP2018-11-05
15060541640143NOxBOXiNOXBOX LTDMRP2018-11-05
05060541640030NOxBOXiNOXBOX LTDMRP2018-11-05
05060541640047NOxBOXiNOXBOX LTDMRP2018-11-05
05060541640054NOxBOXiNOXBOX LTDMRP2018-11-05
05060541640061NOxBOXiNOXBOX LTDMRP2018-11-05
05060541640078NOxBOXiNOXBOX LTDMRP2018-11-05
05060541640085NOxBOXiNOXBOX LTDMRP2018-11-05