NOxBOXi NOXKIT EMER LGENOXKIT-EMER

GUDID 00850046301131

NOxBOXi NOXKIT EMER patient Kit for use with the NOxBOXi nitric oxide delivery device.

Linde Gas & Equipment Inc.

Nitric oxide delivery unit, system-based
Primary Device ID00850046301131
NIH Device Record Keya15c76ff-67e9-4c83-8703-eb5319afa17d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOxBOXi NOXKIT EMER
Version Model Number1
Catalog NumberLGENOXKIT-EMER
Company DUNS042845636
Company NameLinde Gas & Equipment Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850046301124 [Primary]
GS100850046301131 [Package]
Contains: 00850046301124
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

MRPAnalyzer, Nitric Oxide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-09
Device Publish Date2023-05-01

Devices Manufactured by Linde Gas & Equipment Inc.

00850046301209 - NOxBOXi NOXKIT 3-222024-02-05 NOxBOXi NOXKIT 3-22 Patient Kit for use with the NOxBOXi nitric oxide delivery device.
00850046301223 - NOxBOXi NOXKIT 3-HFJV2024-02-05 NOxBOXi NOXKIT3-HFJV patient Kit for use with the NOxBOXi nitric oxide delivery device.
00850046301155 - NOxBOXi NOxFLOW2023-09-07
00850046301162 - MediPure Lung Diffusion Mixture2023-08-23 Lung Diffusion Mixture (of Specified Concentration) GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
00850046301179 - MediPure Blood Gas Mixture2023-08-23 Blood Gas Mixture (of Specified Concentration) GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Blood Gas Mixture
00850046301186 - MediPure Laser Gas Mixture2023-08-23 Laser Gas Mixtures (of Specified Concentration) Gas, Laser Generating - Laser Gas
00850046301193 - MediPure Calibration Gas Mixtures2023-08-23 Calibration Gas Mixtures (of Specified Concentration) GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Calibration Gas Mixture
00850046301032 - NOxBOXi NOXKIT 1-102023-05-09 NOxBOXi NOXKIT 1-10 patient Kit for use with the NOxBOXi nitric oxide delivery device.

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