Respironics California, Inc.

Address:2271 Cosmos Ct,CARLSBAD,CA,92011,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ventilator, continuous, minimal ventilatory support, facility use (MNT) (9) VENTILATOR, NON-CONTINUOUS (RESPIRATOR) (BZD) (1)

Premarket Exempt

Clear

DreamWear Full - 00606959045965 Catalog Number : 1133411

Device Description : M, DreamWear Full, Sm Frm WO HGR, GBL

Device Class : 2

Duns Number: 079550876

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PHILIPS - 00884838009844 Catalog Number : 1053613

Device Description : V60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV

Device Class : 2

Duns Number: 079550876

Premarket Exempt : No

Product Code : MNT

Prescription Use : Yes

Device Count : 1

PHILIPS - 00884838009851 Catalog Number : 1053614

Device Description : V60 Ventilator,Intl Opt: CFLEX,AVAPS

Device Class : 2

Duns Number: 079550876

Premarket Exempt : No

Product Code : MNT

Prescription Use : Yes

Device Count : 1

PHILIPS - 00884838009868 Catalog Number : 1053615

Device Description : V60 Ventilator, Intl Opt: None

Device Class : 2

Duns Number: 079550876

Premarket Exempt : No

Product Code : MNT

Prescription Use : Yes

Device Count : 1

PHILIPS - 00884838015722 Catalog Number : 989805615991

Device Description : Cfgkit,V60,DISS,Grn,Ff,Cord:Schuko

Device Class : 2

Duns Number: 079550876

Premarket Exempt : No

Product Code : MNT

Prescription Use : Yes

Device Count : 1

PHILIPS - 00884838015739 Catalog Number : 989805616001

Device Description : Cfgkit,V60,NIST,Wht,Ff,Cord:UK

Device Class : 2

Duns Number: 079550876

Premarket Exempt : No

Product Code : MNT

Prescription Use : Yes

Device Count : 1

PHILIPS - 00884838015753 Catalog Number : 989805616021

Device Description : Cfgkit,V60,NIST/Afnor,Wht,Fm,Cord:Schuko

Device Class : 2

Duns Number: 079550876

Premarket Exempt : No

Product Code : MNT

Prescription Use : Yes

Device Count : 1

PHILIPS - 00884838015791 Catalog Number : 989805616061

Device Description : Cfgkit,V60,DISS,Grn,Ff,Cord:UK

Device Class : 2

Duns Number: 079550876

Premarket Exempt : No

Product Code : MNT

Prescription Use : Yes

Device Count : 1

PHILIPS - 00884838015807 Catalog Number : 989805616071

Device Description : Cfgkit,V60,NIST,Wht,Ff,Cord:SchUKo

Device Class : 2

Duns Number: 079550876

Premarket Exempt : No

Product Code : MNT

Prescription Use : Yes

Device Count : 1

PHILIPS - 00884838015821 Catalog Number : 989805616081

Device Description : Cfgkit,V60,NIST/Unifor,Wht,Fm,Cord:Italy

Device Class : 2

Duns Number: 079550876

Premarket Exempt : No

Product Code : MNT

Prescription Use : Yes

Device Count : 1

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