Duns Number:006320915
Device Description: The Next Generation Portable Therapeutic Liquid Oxygen System (NPTLOX) is a low pressure p 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.
Catalog Number
50C-0083-1
Brand Name
Next Generation Portable Therapeutic Liquid Oxygen System
Version/Model Number
50C-0083-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K033000
Product Code
BYJ
Product Code Name
Unit, Liquid-Oxygen, Portable
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |