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) (7) METER, PEAK FLOW, SPIROMETRY (BZH) (3)

Premarket Exempt

Yes No

Clear

OptiChamber Diamond - 00383730000503 Catalog Number : 1103006

Device Description : DIAMOND WITH SM MASK-PREFERRED PLUS

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

OptiChamber Diamond - 00383730000510 Catalog Number : 1103007

Device Description : DIAMOND WITH LG MASK-PREFERRED PLUS

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

OptiChamber Diamond - 00383730000527 Catalog Number : 1103038

Device Description : DIAMOND WITH MED MASK-PREFERRED PLUS

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

INNSOPIRE GO Europe1ROW - 00383730000534 Catalog Number : 1126593

Device Description : INNSOPIRE GO Europe1ROW

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

INNOSPIRE GO LITETOUCH LARGE MASK - 00383730000541 Catalog Number : 1127875

Device Description : INNOSPIRE GO LITETOUCH LARGE MASK

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

INNOSPIRE GO LITETOUCH SMALL MASK - 00383730000558 Catalog Number : 1127822

Device Description : INNOSPIRE GO LITETOUCH SMALL MASK

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

INNOSPIRE GO LITETOUCH MEDIUM MASK - 00383730000565 Catalog Number : 1127798

Device Description : INNOSPIRE GO LITETOUCH MEDIUM MASK

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

ASTHMA CHECK - 00383730000572 Catalog Number : HS740

Device Description : ASTHMA CHECK FR PFM ASSY

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

ASTHMA CHECK - 00383730000596 Catalog Number : HS740-012

Device Description : ASTHMACHECK FR PFM(740) - 12-pack

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

ASTHMA CHECK - 00383730000602 Catalog Number : HS74001-CHEST

Device Description : ASTHMACHECK FR PFM - 12-pack - CUSTOM CHEST

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

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