HOMESTYLE Aspen SCE1000-NANB

GUDID M766SCE1000NANB0

Oxygen Concentrator, 1-5 LPM

CAIRE INC.

Stationary oxygen concentrator

• Primary Device ID: M766SCE1000NANB0
• NIH Device Record Key: 9f92e00f-9979-4b49-8e8e-91f23b4e261f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOMESTYLE Aspen
• Version Model Number: SCE1000-NANB
• Catalog Number: SCE1000-NANB
• Company DUNS: 807537683
• Company Name: CAIRE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com
• Phone: 770-721-7700
• Email: customerservice.usa@caireinc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M766SCE1000NANB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202389

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-08
• Device Publish Date: 2025-06-30

Devices Manufactured by CAIRE INC.

• M766SCE1000NANB0 - HOMESTYLE Aspen: 2025-07-08Oxygen Concentrator, 1-5 LPM
• M766SCE1000NANB0 - HOMESTYLE Aspen: 2025-07-08 Oxygen Concentrator, 1-5 LPM
• M766214997340 - IntenOxy 5: 2024-11-21 Oxygen Concentrator, 1-5 LPM
• M766AS2006R0 - Arya: 2024-11-21 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Single Battery, Refurbished
• M766AS2001R0 - FreeStyle Comfort: 2024-08-19 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English Single Battery
• 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