NOxBOXi NXBNOXBOX-I

GUDID 05060541640016

Nitric Oxide Delivery and Monitoring System - Head Unit Only

NOXBOX LTD

Nitric oxide delivery unit, system-based

• Primary Device ID: 05060541640016
• NIH Device Record Key: 2f4a4dcd-a8cf-413f-8672-bd89bb777efd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOxBOXi
• Version Model Number: NOXBOX-I
• Catalog Number: NXBNOXBOX-I
• Company DUNS: 220841986
• Company Name: NOXBOX LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-833-669-8368
• Email: NoxiventUS@Praxair.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 800 millibar and 1200 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 800 millibar and 1200 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060541640009 [Direct Marking]
GS1	05060541640016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171696

FDA Product Code

• CCL: Analyzer, Gas, Oxygen, Gaseous-Phase

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: 2018-12-06
• Device Publish Date: 2018-11-05

On-Brand Devices [NOxBOXi]

• 05060541640191: Calibration Gas NO2
• 05060541640184: Calibration gas NO
• 25060541640089: Single use connections kit for Bunnell Jet ventilator
• 25060541640072: System Test kit
• 25060541640065: Single use 12mm size 2 delivery and sampling kit
• 25060541640058: Single use 10mm delivery and sampling kit
• 25060541640041: Single use 15mm size 2 delivery and sampling kit
• 25060541640034: Single use 22mm size 2 delivery and sampling kit
• 05060541640023: Nitric Oxide Delivery and Monitoring System - Head unit and Trolley
• 05060541640016: Nitric Oxide Delivery and Monitoring System - Head Unit Only
• 15060541640167: Single use tubing for connection between NOxMixer and NOxFLOW during back up mode
• 95060541640149: Single use connector 22M/15F-15M Gas Sampling Port
• 95060541640132: Single use 50mm Nebuliser filter
• 95060541640125: Single use 25mm Disk Filter for water trap
• 95060541640118: Single use 22mm one-way valve for use with Sensor Medics 3100A/B HFO ventilators