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

METER, PEAK FLOW, SPIROMETRY (BZH) (5) Nebulizer (direct patient interface) (CAF) (4)

Premarket Exempt

No Yes

Clear

I-neb Generic ClinicalStudy Disc Power10 - 00383730004518 Catalog Number : 1124498

Device Description : I-neb Generic Clinical Study Disc Power10

Device Class : 2

Duns Number: 220018415

Premarket Exempt : Yes

Product Code : CAF

Prescription Use : Yes

Device Count : 1

ASTHMACHECK - 00383730004563 Catalog Number : HS002068-010

Device Description : Peak Flow Meter - Pk of 10

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : Yes

Device Count : 1

I-neb In Vitro Test Disc Power 10 - 00383730004587 Catalog Number : 1003419

Device Description : I-neb In Vitro Test Disc Power 10

Device Class : 2

Duns Number: 220018415

Premarket Exempt : Yes

Product Code : CAF

Prescription Use : Yes

Device Count : 1

I-neb In Vitro Test Disc Power 12 - 00383730004594 Catalog Number : 1003778

Device Description : I-neb In Vitro Test Disc Power 12

Device Class : 2

Duns Number: 220018415

Premarket Exempt : Yes

Product Code : CAF

Prescription Use : Yes

Device Count : 1

I-neb In Vitro Test Disc Power 6 - 00383730004600 Catalog Number : 1109797

Device Description : I-neb In Vitro Test Disc Power 6

Device Class : 2

Duns Number: 220018415

Premarket Exempt : Yes

Product Code : CAF

Prescription Use : Yes

Device Count : 1

OVAL DISPOSABLE PLASTIC MOUTHPIECE - 00383730004617 Catalog Number : HS757-100

Device Description : OVAL DISPOSABLE PLASTIC MOUTHPIECE

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

PLASTIC PEDIATRIC MOUTHPIECES (715)100PK - 00383730004624 Catalog Number : HS715-100

Device Description : PLASTIC PEDIATRIC MOUTHPIECES (715)100PK

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE - 00383730004631 Catalog Number : HS715

Device Description : PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

OVAL MOUTHPIECE - 00383730004648 Catalog Number : 1136960

Device Description : OVAL MOUTHPIECE

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

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