AccessGUDID - DEVICE: Next Generation Portable Therapeutic Liquid Oxygen System (10815363020032)

GUDID

Device Identifier (DI) Information

Brand Name: Next Generation Portable Therapeutic Liquid Oxygen System
Version or Model: 50C-0083-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50C-0083-1
Company Name: ESSEX INDUSTRIES, INC.

Primary DI Number: 10815363020032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006320915 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYJ	Unit, Liquid-Oxygen, Portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033000	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6fcc47ee-3483-4cb6-b9b7-a99c01fc9e68
Public Version Date: October 23, 2019
Public Version Number: 4
DI Record Publish Date: July 18, 2016