NOxBOXi

Basic Information

• Brand Name: NOxBOXi
• Primary DI: 15060541640129
• Version / Model: FIL063
• Catalog Number: NXBFIL063
• Company Name: NOXBOX LTD
• Labeler DUNS: 220841986
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-11-05
• Public Version: 1
• Public Version Date: 2018-12-06
• Public Version Status: New
• Public Device Record Key: 59dac82a-8359-43b1-8632-ff05b2dd15c3

Device Description

Single use 25mm Disk Filter for water trap

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	868.1720	2
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	868.2385	2
MRP	Analyzer, Nitric Oxide	Anesthesiology	868.2380	2
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	868.5165	2
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	868.5165	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37266	Nitric oxide delivery unit, system-based	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	95060541640125	GS1	BOX	999999999	In Commercial Distribution
Primary	15060541640129	GS1
Unit of Use	05060541640122	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171696	000

Storage Conditions

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