NOxBOXi NXB034-20-01010-V

GUDID 05060541640191

Calibration Gas NO2

NOXBOX LTD

Nitric oxide delivery unit, system-based
Primary Device ID05060541640191
NIH Device Record Keyaf5e6041-2df4-4d46-bd6f-5bbff1a0e9ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOxBOXi
Version Model Number034-20-01010-V
Catalog NumberNXB034-20-01010-V
Company DUNS220841986
Company NameNOXBOX LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-833-669-8368
EmailNoxiventUS@Praxair.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 800 millibar and 1200 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 800 millibar and 1200 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS105060541640191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-06
Device Publish Date2018-11-05

On-Brand Devices [NOxBOXi]

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

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