FDA.reportPublic FDA data

NOxBOXi NOXKIT 1-10

Primary DI
00850046301032
Brand
NOxBOXi NOXKIT 1-10
Company
Linde Gas & Equipment Inc.
Model
1
Catalog number
LGENOXKIT-1-10
Device description
NOxBOXi NOXKIT 1-10 patient Kit for use with the NOxBOXi nitric oxide delivery device.
Published
2023-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00850046301032PackageGS110In Commercial Distribution
00850046301025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046301032008500463010328500463010320850046301032
00850046301025008500463010258500463010250850046301025

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
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042845636
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
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
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
00850046301001NOxBOXi System-I Test Kit12023-02-13

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
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
00850046301001NOxBOXi System-I Test KitLinde Gas & Equipment Inc.MRP2023-02-13
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