Portable Therapeutic Liquid Oxygen System 50C-0021-1

GUDID 10815363020025

The Portable Therapeutic Liquid Oxygen System (PTLOX) is a low pressure portable 10.0 liter liquid oxygen storage and gaseous delivery system, capable of supplying up to 8600 gaseous liters of oxygen at a maximum flow rate of 45 liters per minute at 50 psig. The unit features three quick disconnect outlet ports and comes with an accessory kit containing three 20 foot medical grade hoses, three flow control valves and three humidifier bottles. 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. Weighing less than 100 pounds when full, the PTLOX can be carried by two ground support personnel or mounted in an aircraft. The PTLOX requires no external power and uses just two 9-Volt batteries for the quantity indicator. The system has been tested to MIL-STD-810.

ESSEX INDUSTRIES, INC.

Portable liquid oxygen unit

• Primary Device ID: 10815363020025
• NIH Device Record Key: 55f9e4e8-d9f6-4051-943f-5af7422b4212
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portable Therapeutic Liquid Oxygen System
• Version Model Number: 50C-0021-1
• Catalog Number: 50C-0021-1
• Company DUNS: 006320915
• Company Name: ESSEX INDUSTRIES, 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: 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: 314.832.4500
• Email: info@essexind.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815363020025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880183

FDA Product Code

• BYJ: Unit, Liquid-Oxygen, Portable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-07-18

Devices Manufactured by ESSEX INDUSTRIES, INC.

• 10815363020001 - Oxygen Generator and Liquifier: 2020-04-20 The Oxygen Generator and Liquefier (OGL) is a portable oxygen generating and liquefaction system, capable of producing up to 15
• 10815363020018 - Oxygen Generator and Liquifier: 2020-04-20 The Oxygen Generator and Liquefier (OGL) is a portable oxygen generating and liquefaction system, capable of producing up to 15
• 10815363020025 - Portable Therapeutic Liquid Oxygen System: 2019-10-23The Portable Therapeutic Liquid Oxygen System (PTLOX) is a low pressure portable 10.0 liter liquid oxygen storage and gaseous delivery system, capable of supplying up to 8600 gaseous liters of oxygen at a maximum flow rate of 45 liters per minute at 50 psig. The unit features three quick disconnect outlet ports and comes with an accessory kit containing three 20 foot medical grade hoses, three flow control valves and three humidifier bottles. 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. Weighing less than 100 pounds when full, the PTLOX can be carried by two ground support personnel or mounted in an aircraft. The PTLOX requires no external power and uses just two 9-Volt batteries for the quantity indicator. The system has been tested to MIL-STD-810.
• 10815363020025 - Portable Therapeutic Liquid Oxygen System: 2019-10-23 The Portable Therapeutic Liquid Oxygen System (PTLOX) is a low pressure portable 10.0 liter liquid oxygen storage and gaseous de
• 10815363020032 - Next Generation Portable Therapeutic Liquid Oxygen System: 2019-10-23 The Next Generation Portable Therapeutic Liquid Oxygen System (NPTLOX) is a low pressure portable 20.0 liter liquid oxygen stora