RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

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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

NEBULIZER (DIRECT PATIENT INTERFACE) (CAF) (6) Compressor, air, portable (BTI) (3) MASK, OXYGEN (BYG) (1)

Premarket Exempt

No Yes

Clear

OPTICHAMBER DIAMOND - 00383730003900 Catalog Number : 1126699

Device Description : OPTICHAMBER DIAMOND WSMALL MASK CHINA (P10)

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

OPTICHAMBER DIAMOND - 00383730003917 Catalog Number : 1126537

Device Description : OPTICHAMBER DIAMOND WMED MASK CHINA (P10)

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

OPTICHAMBER DIAMOND - 00383730003924 Catalog Number : 1126536

Device Description : OPTICHAMBER DIAMOND WLG MASK CHINA (P10)

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

I-NEB - 00383730003931 Catalog Number : 1129974

Device Description : I-NEB DISC.

Device Class : 2

Duns Number: 220018415

Premarket Exempt : Yes

Product Code : CAF

Prescription Use : Yes

Device Count : 1

System 22 - 00383730003948 Catalog Number : 1025531

Device Description : MASK - SIDESTREAM ADULT

Device Class : 1

Duns Number: 220018415

Premarket Exempt : No

Product Code : BYG

Prescription Use : No

Device Count : 1

Innospire Go Mouthpiece Assembly - 00383730003962 Catalog Number : 1128501

Device Description : Innospire Go Mouthpiece Assembly

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

INNOSPIRE MINI - 00383730003979 Catalog Number : 1125473

Device Description : CUSTOM INNOSPIRE MINI MED4HOME, 6 pk.

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Innospire Elegance 230v50hz Germany - 00383730003986 Catalog Number : 1130122

Device Description : Innospire Elegance 230v50hz Germany

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BTI

Prescription Use : No

Device Count : 1

Innospire Essence - 00383730003993 Catalog Number : 1129542

Device Description : INNOSPIRE ESSENCE COMPRESSOR NEBULIZER SYSTEM, CUSTOM FOR NEB MED SERVICES

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BTI

Prescription Use : Yes

Device Count : 1

INNOSPIRE ESSENCE - 00383730004006 Catalog Number : 1129539

Device Description : INNOSPIRE ESSENCE COMPRESSOR NEBULIZER SYSTEM, CUSTOMIZED FOR NEB MEDICAL SERVICES

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BTI

Prescription Use : Yes

Device Count : 1

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