ECLIPSE 3

GUDID M7665909SEQ0

OXYGEN CONCENTRATOR, PORTABLE, 3LPM, SYS, EN, EURO

CAIRE INC.

Mobile/portable oxygen concentrator

• Primary Device ID: M7665909SEQ0
• NIH Device Record Key: cc7f35e0-5cb8-4741-bff3-0f8abc484a5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECLIPSE 3
• Version Model Number: 5909-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	M7665909SEQ0 [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.

• M766AS2001060 - Arya: 2021-11-16 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Double Battery
• M766AS2002060 - Arya: 2021-11-16 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Two Single Batteries
• M766AS20060 - Arya: 2021-11-16 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Single Battery
• M76613256929SM0 - Liberator: 2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner
• M76613256961SM0 - Liberator: 2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner
• M76613256996SM0 - Liberator: 2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner
• M76613258385SM0 - Liberator: 2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner
• M76613258406SM0 - Liberator: 2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner