FDA.reportPublic FDA data

CAIRE INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049723043004972304CAIRE INC.1N2026-01-012200 Airport Industrial Dr Ste 500 Ball Ground GA US 30107
30091287342129616CAIRE INC.1Y2026-01-012205 Airport Industrial Dr Ball Ground GA US 30107
30095506193009550619CAIRE Medical Technology (Chengdu) Co., Ltd.1N2026-01-011/F, Building 4, No. 670 Haifa Road Chengdu Cross-Strait Science and Technology Indu Chengdu Sichuan CN 611138
20305051000519984CAIRE INC.1N2020-04-257736 Clairemont Mesa Blvd. San Diego CA US 92111

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
143901418500801K993220PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEMBYJ1999-10-22
1298391418500801K993220PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEMBYJ1999-10-22
1298391002878541K960309AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)CAW1997-02-28
143901002878541K960309AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)CAW1997-02-28
143901368592851K873901COMPANION MINI OXYGEN SAVERNFB1987-12-02
1298391368592851K873901COMPANION MINI OXYGEN SAVERNFB1987-12-02
1392371397070964K8725344LYF OXYGEN CONCENTRATORCAW1987-10-13
1298391397070964K8725344LYF OXYGEN CONCENTRATORCAW1987-10-13
143901397070964K8725344LYF OXYGEN CONCENTRATORCAW1987-10-13
1298391130695653K861503COMPANION LIQUID OXYGEN SYSTEMBYJ1986-06-25
143901130695653K861503COMPANION LIQUID OXYGEN SYSTEMBYJ1986-06-25
1298392015651006K860937MARK 4 LIQUID OXYGEN SYSTEMBYJ1986-03-20
143902015651006K860937MARK 4 LIQUID OXYGEN SYSTEMBYJ1986-03-20
143901819736383K830498LIQUID OXYGEN SYSTEMBYJ1983-03-10
1298391819736383K830498LIQUID OXYGEN SYSTEMBYJ1983-03-10
143901848460205K800742LIBERATOR/STROLLER II SYSTEMBYJ1980-05-23
1298391848460205K800742LIBERATOR/STROLLER II SYSTEMBYJ1980-05-23
143901456090086K250671FreeStyle Comfort (AS200 / FreeStyle Comfort)CAW2025-07-11
1298391456090086K250671FreeStyle Comfort (AS200 / FreeStyle Comfort)CAW2025-07-11
143901394608005K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5ACAW2023-04-28
143901971730841K202389Oxygen ConcentratorCAW2022-04-08
1298391971730841K202389Oxygen ConcentratorCAW2022-04-08
1248001340961078K150930Deployable Oxygen Generation System-Smaill (DOGS-S)CAW2015-12-18
143901340961078K150930Deployable Oxygen Generation System-Smaill (DOGS-S)CAW2015-12-18
143901404009109K121167CAIRE COMPANION 5 OXYGEN CONCENTRATORCAW2012-05-02
1298391404009109K121167CAIRE COMPANION 5 OXYGEN CONCENTRATORCAW2012-05-02
1298391836221427K120785OMNI 3 OXYGEN SYSTEMCAW2012-10-25
1298391246976285K083163OMNI 2 OXYGEN SYSTEMCAW2009-10-20
143901246976285K083163OMNI 2 OXYGEN SYSTEMCAW2009-10-20
1298391111712053K080023MODIFICATION TO: SPIRITBYJ2008-06-16
143901111712053K080023MODIFICATION TO: SPIRITBYJ2008-06-16
143902032393519K020324LIFESTYLE OXYGEN CONCENTRATORCAW2002-03-13
1298392032393519K020324LIFESTYLE OXYGEN CONCENTRATORCAW2002-03-13
143901065852468K013931OMNI OXYGEN SYSTEM, MODEL 1000CAW2002-03-27
1298391065852468K013931OMNI OXYGEN SYSTEM, MODEL 1000CAW2002-03-27
1392371065852468K013931OMNI OXYGEN SYSTEM, MODEL 1000CAW2002-03-27
1298391523486424
143901523486424

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAW222025-07-11
BYJ122008-06-16
NFB21987-12-02

PMN#

GUDID#

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