HOMESTYLE Aspen SCE1000-NANB

GUDID M766SCE1000NANB0

Oxygen Concentrator, 1-5 LPM

CAIRE INC.

Stationary oxygen concentrator
Primary Device IDM766SCE1000NANB0
NIH Device Record Key9f92e00f-9979-4b49-8e8e-91f23b4e261f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHOMESTYLE Aspen
Version Model NumberSCE1000-NANB
Catalog NumberSCE1000-NANB
Company DUNS807537683
Company NameCAIRE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com
Phone770-721-7700
Emailcustomerservice.usa@caireinc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM766SCE1000NANB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAWGenerator, Oxygen, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-08
Device Publish Date2025-06-30

Devices Manufactured by CAIRE INC.

M766AS2001410 - CAIRE Inc.2025-08-21 FreeStyle Comfort Oxygen Concentrator with autoSAT function, double battery
M766AS2001460 - Arya2025-08-21 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 - Arya2025-08-21 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 - Arya2025-08-21 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 Aspen2025-07-08Oxygen Concentrator, 1-5 LPM
M766SCE1000NANB0 - HOMESTYLE Aspen2025-07-08 Oxygen Concentrator, 1-5 LPM

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