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Longfian Scitech Co., Ltd. · Model JAY-5 · UDI-DI 06934726614033

CAW

510(k) clearances

52,921

Adverse events (527 deaths)

Recalls

Facilities

Description

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 the oxygen 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

Recalls

Date	Firm	Reason
2026-02-04	3B Medical, Inc.	Devices which did not meet internal quality specifications were inadvertently distributed.
2025-10-07	Philips Respironics, Inc.	Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in
2025-05-08	Ohio Medical Corporation	Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purit
2025-04-11	Medical Depot Inc.	Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
2024-12-09	JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD	Oxygen concentrator may melt or catch on fire during use.
2024-10-04	Caire, Inc.	Potential failure of affected units to recharge the battery of the oxygen concentrators.
2024-10-04	Caire, Inc.	Potential failure of affected units to recharge the battery of the oxygen concentrators.
2024-10-04	Caire, Inc.	Potential failure of affected units to recharge the battery of the oxygen concentrators.
2024-10-04	Caire, Inc.	Potential failure of affected units to recharge the battery of the oxygen concentrators.
2023-03-09	DeVilbiss Healthcare LLC	The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.