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

SPIROMETER, THERAPEUTIC (INCENTIVE) (BWF) (6) Holding chambers, direct patient interface (NVP) (2) METER, PEAK FLOW, SPIROMETRY (BZH) (1) NEBULIZER (DIRECT PATIENT INTERFACE) (CAF) (1)

Premarket Exempt

No Yes

Clear

PERSONAL BEST FR PFM - AUSTRALIA - 00383730000619 Catalog Number : 1050365

Device Description : PERSONAL BEST FR PFM - AUSTRALIA

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

OptiChamber Diamond - 00383730000626 Catalog Number : 1099014

Device Description : ASTHMA PACK FOR ADULTS, 10 Pack

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : NVP

Prescription Use : Yes

Device Count : 1

OptiChamber Diamond - 00383730000633 Catalog Number : 1099015

Device Description : ASTHMAPACK FOR CHILDREN, 10-Pack

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : NVP

Prescription Use : Yes

Device Count : 1

ACDC Power Adapter (EU) - 00383730000640 Catalog Number : 1127650

Device Description : ACDC Power Adapter (EU)

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

ProChamber Assembly - 00383730000657 Catalog Number : HS-006

Device Description : ProChamber Assembly

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

PROCHAMBER Assembly - 00383730000664 Catalog Number : 1040191

Device Description : PROCHAMBER SPAIN - 10PK

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

PROCHAMBER Assembly - 00383730000671 Catalog Number : 1069177

Device Description : PROCHAMBER RETAIL - 10PK

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

ProChamber Assembly - 00383730000688 Catalog Number : 1117488

Device Description : PROCHAMBER WITH LARGE SILICONE MASK 50-pack

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

ProChamber Assembly - 00383730000695 Catalog Number : 1117489

Device Description : PROCHAMBER WITH SMALL SILICONE MASK 50-pack

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

ProChamber Assembly - 00383730000701 Catalog Number : 1117490

Device Description : PROCHAMBER WMEDIUM SILICONE MASK 50-pack

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

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