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) Holding chambers, direct patient interface (NVP) (2) METER, PEAK FLOW, SPIROMETRY (BZH) (1)

Premarket Exempt

No Yes

Clear

OptiChamber Diamond - 00383730000244 Catalog Number : 1079827

Device Description : OC DIAMOND W LARGE MASK 10 PK- US

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

OPTICHAMBER DIAMOND - 00383730000251 Catalog Number : 1079828

Device Description : OPTICHAMBER DIAMOND W LRG MSK- ROW

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

OptiChamber Diamond - 00383730000268 Catalog Number : 1079830

Device Description : OC DIAMOND 50 PACK

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : NVP

Prescription Use : Yes

Device Count : 1

OPTICHAMBER DIAMOND - 00383730000329 Catalog Number : 1098213

Device Description : OPTICHAMBER DIAMOND - 10-PACK CANADA

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : NVP

Prescription Use : No

Device Count : 1

OPTICHAMBER DIAMOND - 00383730000336 Catalog Number : 1098214

Device Description : OPTICHAMBER DIAMOND W SM MASK- CANADA

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

OPTICHAMBER DIAMOND - 00383730000343 Catalog Number : 1098215

Device Description : OPTICHAMBER DIAMOND W MED MASK CANADA

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

OPTICHAMBER DIAMOND - 00383730000350 Catalog Number : 1098216

Device Description : OPTICHAMBER DIAMOND W LG MASK CANADA

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

OPTICHAMBER DIAMOND - 00383730000374 Catalog Number : 1109060

Device Description : OPTICHAMBER DIAMOND WSML MASK (RUSSIA)

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

OPTICHAMBER DIAMOND - 00383730000381 Catalog Number : 1109094

Device Description : OPTICHAMBER DIAMOND WMED MASK (RUSSIA)

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

PERSONAL BEST - 00383730000398 Catalog Number : 1024941

Device Description : PERSONAL BEST ISO ASSEMBLY

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

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