eQuinox Oxygen Concentrator

GUDID M7664837SEQ0

Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings, Multi-language Voice Interface, 24 cell battery

CAIRE INC.

Mobile/portable oxygen concentrator

• Primary Device ID: M7664837SEQ0
• NIH Device Record Key: 99277626-79fb-48e6-9251-fb7eaa75e048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eQuinox Oxygen Concentrator
• Version Model Number: 4837-SEQ
• Company DUNS: 807537683
• Company Name: CAIRE INC.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7664837SEQ0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120785

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: 2016-05-16

On-Brand Devices [eQuinox Oxygen Concentrator]

• M7664837SEQ0: Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings, Multi-language Voice
• M7664807SEQ0: Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings, Multi-language Voice
• M7664807CSEQ0: Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings, Multi-language Voice