Eclipse 3 Assembly, Re-Manufactured

GUDID M7665985CSEQ0

Eclipse 3 Assembly, Re-Manufactured

CAIRE INC.

Mobile/portable oxygen concentrator

• Primary Device ID: M7665985CSEQ0
• NIH Device Record Key: 414ceac5-787f-44ce-aeb5-90e0a87c51af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse 3 Assembly, Re-Manufactured
• Version Model Number: 5985C-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	M7665985CSEQ0 [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: 2
• Public Version Date: 2020-04-20
• Device Publish Date: 2018-09-11

Devices Manufactured by CAIRE INC.

• M766AS2001410 - CAIRE Inc.: 2025-08-21 FreeStyle Comfort Oxygen Concentrator with autoSAT function, double battery
• M766AS2001460 - Arya: 2025-08-21 Ayra Portable Oxygen Concentrator, double battery, autoSAT function 4 btn.
• M766AS2002410 - CAIRE Inc.: 2025-08-21 FreeStyle Comfort Oxygen Concentrator with autoSAT function, 2 single batteries
• M766AS2002460 - Arya: 2025-08-21 Arya Portable Oxygen Concentrator, 2 single batteries, autoSAT function, 4 btn
• M766AS200410 - CAIRE Inc.: 2025-08-21 FreeStyle Comfort Portable Oxygen Concentrator with autoSAT function and single battery
• M766AS200460 - Arya: 2025-08-21 Ayra Portable Oxygen Concentrator, single battery with autoSAT function, 4 btn.
• M766AS200SW410 - CAIRE Inc.: 2025-08-21 FreeStyle Comfort Portable Oxygen Concentrator with autoSAT function, no accessories included device only.
• M766SCE1000NANB0 - HOMESTYLE Aspen: 2025-07-08 Oxygen Concentrator, 1-5 LPM