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 |