Duns Number:543435019
Device Description: JAY-5 medical oxygen concentrator adopts pressure swing adsorption principle, which can se JAY-5 medical oxygen concentrator adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally theoxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.The concentrator can supply 1-2 patients simultaneously, with steady oxygen flowing out and reliable, adjustable flow. The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The key parts of the generator adopt anti-tiring and anti-aging design, and the planned life of the whole generator reaches up to 20,000 hours. The weight of Jay-5 is around 25kg (~55lbs). There is no influence on indoor oxygen percent during the generator operating.JAY-5 medical oxygen concentrator contains the following items: One (1) Jay-5 Oxygen Concentrator Unit One (1) AC Power Supply One (1) Nasal Oxygen Tube One (1) Humidifier One (1) Operation Manual
Catalog Number
-
Brand Name
Longfian
Version/Model Number
JAY-5
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
K131968
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
64edc9b6-bb12-46be-b1d3-83cd0e721f75
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
October 24, 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. | 1 |