| 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 |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com | |
| Phone | 770-721-7700 |
| customerservice.usa@caireinc.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M766SCE1000NANB0 [Primary] |
| CAW | Generator, Oxygen, Portable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-08 |
| Device Publish Date | 2025-06-30 |
| 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 | 2025-07-08Oxygen Concentrator, 1-5 LPM |
| M766SCE1000NANB0 - HOMESTYLE Aspen | 2025-07-08 Oxygen Concentrator, 1-5 LPM |