Eclipse Oxygen Concentrator

GUDID M7666900BTSEQ0

Eclipse 5 Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings, Bluetooth

CAIRE INC.

Mobile/portable oxygen concentrator

• Primary Device ID: M7666900BTSEQ0
• NIH Device Record Key: 58ba74f4-7e12-416c-8baa-617a6d7d7c76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse Oxygen Concentrator
• Version Model Number: 6900BT-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	M7666900BTSEQ0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013931

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: 2018-01-30

On-Brand Devices [Eclipse Oxygen Concentrator]

• M7666900SEQ0: Eclipse 5 Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings
• M7666900LNSEQ0: Eclipse 5 Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings, 2 Batterie
• M7666900CSEQ0: Eclipse 5 Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings, Certified
• M7666900BTSEQ0: Eclipse 5 Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings, Bluetooth
• M7665900SEQ0: Eclipse 3 Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings
• M7665900CSEQ0: Eclipse 3 Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings, Certified