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Portable Therapeutic Liquid Oxygen System

FDA UDI

Class II (US FDA UDI)

by Essex Industries, Inc.

Identity

Trade Name
Portable Therapeutic Liquid Oxygen System FDA UDI
Generic Name
Portable liquid oxygen unit FDA UDI
Device Name
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. FDA UDI
Model / Reference
50C-0021-1 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
50C-0021-1 FDA UDI
Primary DI / UDI-DI
10815363020025 FDA UDI
510(k) Number
K880183 FDA UDI
FDA Product Code
BYJ FDA UDI
GMDN Term
Portable liquid oxygen unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5655 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Portable liquid oxygen unit

Portable Therapeutic Liquid Oxygen System by Essex Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Portable liquid oxygen unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Essex Industries, Inc.

Sources (1)

  • FDA UDI 55f9e4e8-d9f6-4051-943f-5af7422b4212 36 fields · synced May 30, 2026