Next Generation Portable Therapeutic Liquid Oxygen System

Basic Information

• Brand Name: Next Generation Portable Therapeutic Liquid Oxygen System
• Primary DI: 10815363020032
• Version / Model: 50C-0083-1
• Catalog Number: 50C-0083-1
• Company Name: ESSEX INDUSTRIES, INC.
• Labeler DUNS: 006320915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-18
• Public Version: 4
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: 6fcc47ee-3483-4cb6-b9b7-a99c01fc9e68

Device Description

The Next Generation Portable Therapeutic Liquid Oxygen System (NPTLOX) is a low pressure portable 20.0 liter liquid oxygen storage and gaseous delivery system, capable of supplying up to 17,200 gaseous liters of oxygen at a maximum flow rate of 66 liters per minute at 50 psig. The unit features six quick disconnect outlet ports and comes with an accessory kit containing three 20 foot medical grade hoses, three flow control valves, three humidifier bottles and three quick disconnect adapters. The three flow control valves can deliver oxygen to three patients at flow rates from .5 to 15 liters per minute. The quick disconnect outlet ports can also supply 50 psi of oxygen to other medical devices or to oxygen regulators for additional patients. Weighing less than 150 pounds when full, the NPTLOX can be carried by two ground support personnel or mounted in an aircraft. The NPTLOX requires no external power and uses just two 9-Volt batteries for the quantity indicator. The system has been tested to MIL-STD-810.

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
BYJ	Unit, Liquid-Oxygen, Portable	Anesthesiology	868.5655	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35910	Portable liquid oxygen unit	An empty device designed as a portable, supplemental, refillable container intended as a storage for liquid oxygen (LOX) and its conversion into gaseous form for delivery of medical oxygen (O2) at various pulsed or fixed flow settings to a patient who typically has difficulty extracting O2 from the atmosphere. It typically consists of a cryogenic canister containing the LOX, a mechanism (e.g., a warming coil) where the LOX is converted into gas, a gas delivery control device (e.g., demand valve or fixed flow mechanism) that regulates the flow of O2 to the patient, a fill port and an outlet connection for connection of a nasal cannula or face mask.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815363020032	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033000	000