Medical oxygen concentrator

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref JAY-10DRef JAY-5

by Longfian Scitech Co., Ltd.

Identity

Trade Name: Longfian FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: Medical oxygen concentrator EUDAMED
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 FDA UDI
Model / Reference: JAY-10D EUDAMED
JAY-5 EUDAMEDFDA UDI
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 FDA UDI

Identifiers

Primary DI / UDI-DI: 06934726614118 EUDAMED
06934726614033 EUDAMEDFDA UDI
Basic UDI-DI: B-06934726614118 EUDAMED
B-06934726614033 EUDAMED
510(k) Number: K131968 FDA UDI
FDA Product Code: CAW FDA UDI
EMDN Code: Z12159004 OXYGEN CONCENTRATORS EUDAMED
GMDN Term: Mobile/portable oxygen concentrator FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 868.5440 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Medical oxygen concentrator by Longfian Scitech Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06934726614118	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Longfian Scitech Co., Ltd.
EUDAMED SRN: CN-MF-000028163
Authorised Representative: Obelis s.a. BE-AR-000000106

Sources (3)

EUDAMED ba4d8672-455e-4c11-a46d-09c50ca17d10 61 fields · synced Jul 19, 2026
EUDAMED e6707825-5dc8-4b49-b286-a136c5cd775c 61 fields · synced May 19, 2026
FDA UDI 64edc9b6-bb12-46be-b1d3-83cd0e721f75 35 fields · synced May 30, 2026