NOxBOXi NOxFLOW LGENOXFLOW-2

GUDID 00850046301155

Linde Gas & Equipment Inc.

Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based

• Primary Device ID: 00850046301155
• NIH Device Record Key: f498f448-51b9-48bc-94e5-3dcef484667a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOxBOXi NOxFLOW
• Version Model Number: 1
• Catalog Number: LGENOXFLOW-2
• Company DUNS: 042845636
• Company Name: Linde Gas & Equipment Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850046301148 [Primary]
GS1	00850046301155 [Package]; Contains: 00850046301148; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• MRP: Analyzer, Nitric Oxide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-07
• Device Publish Date: 2023-08-30

Devices Manufactured by Linde Gas & Equipment Inc.

• 00850046301209 - NOxBOXi NOXKIT 3-22: 2024-02-05 NOxBOXi NOXKIT 3-22 Patient Kit for use with the NOxBOXi nitric oxide delivery device.
• 00850046301223 - NOxBOXi NOXKIT 3-HFJV: 2024-02-05 NOxBOXi NOXKIT3-HFJV patient Kit for use with the NOxBOXi nitric oxide delivery device.
• 00850046301155 - NOxBOXi NOxFLOW: 2023-09-07
• 00850046301155 - NOxBOXi NOxFLOW: 2023-09-07
• 00850046301162 - MediPure Lung Diffusion Mixture: 2023-08-23 Lung Diffusion Mixture (of Specified Concentration) GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
• 00850046301179 - MediPure Blood Gas Mixture: 2023-08-23 Blood Gas Mixture (of Specified Concentration) GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Blood Gas Mixture
• 00850046301186 - MediPure Laser Gas Mixture: 2023-08-23 Laser Gas Mixtures (of Specified Concentration) Gas, Laser Generating - Laser Gas
• 00850046301193 - MediPure Calibration Gas Mixtures: 2023-08-23 Calibration Gas Mixtures (of Specified Concentration) GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Calibration Gas Mixture
• 00850046301032 - NOxBOXi NOXKIT 1-10: 2023-05-09 NOxBOXi NOXKIT 1-10 patient Kit for use with the NOxBOXi nitric oxide delivery device.