SAROS 15

GUDID M766AS00710

Portable Oxygen Concentrator 0.5-15 LPM, Continuous and Pulse Dose Settings

CAIRE INC.

Mobile/portable oxygen concentrator
Primary Device IDM766AS00710
NIH Device Record Keydb496c24-5aba-4de7-ba91-f89635cb2016
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAROS 15
Version Model NumberAS007-1
Company DUNS807537683
Company NameCAIRE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM766AS00710 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-20
Device Publish Date2017-04-13

Devices Manufactured by CAIRE INC.

M766AS2001060 - Arya2021-11-16 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Double Battery
M766AS2002060 - Arya2021-11-16 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Two Single Batteries
M766AS20060 - Arya2021-11-16 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Single Battery
M76613256929SM0 - Liberator2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner
M76613256961SM0 - Liberator2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner
M76613256996SM0 - Liberator2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner
M76613258385SM0 - Liberator2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner
M76613258406SM0 - Liberator2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner

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