Longfian

GUDID 06934726614033

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

Longfian Scitech Co.,Ltd.

Mobile/portable oxygen concentrator

• Primary Device ID: 06934726614033
• NIH Device Record Key: 64edc9b6-bb12-46be-b1d3-83cd0e721f75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Longfian
• Version Model Number: JAY-5
• Company DUNS: 543435019
• Company Name: Longfian Scitech Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3056094701
• Email: marina-shee@longfian.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934726614033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131968

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-20
• Device Publish Date: 2016-10-24