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) (9) Holding chambers, direct patient interface (NVP) (1)

Premarket Exempt

No Yes

Clear

PERSONAL BEST - 00383730000404 Catalog Number : 1022973

Device Description : PERSONAL BEST FR PFM ISO-23747 SINGLE

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

PERSONAL BEST - 00383730000411 Catalog Number : 1029435

Device Description : PERSONAL BEST FR PFM - CEGLA (ISO 23747)

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

PERSONAL BEST - 00383730000428 Catalog Number : HS755

Device Description : PERSONAL BEST FR PFM ASSY

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

PERSONAL BEST - 00383730000435 Catalog Number : HS755-012

Device Description : PERSONAL BEST FR PFM (755) - 12PK

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

PERSONAL BEST - 00383730000442 Catalog Number : 1023833

Device Description : PERSONAL BEST FR PFM-RUSSIA-SINGLE UNIT

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

PERSONAL BEST - 00383730000459 Catalog Number : HS756

Device Description : PERSONAL BEST LR PFM ASSY

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

PERSONAL BEST - 00383730000466 Catalog Number : 1023870

Device Description : PERSONAL BEST LR PFM-RUSSIA-SINGLE UNIT

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

PERSONAL BEST - 00383730000473 Catalog Number : HS756-012

Device Description : PERSONAL BEST LR PFM (756)-12PK

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

PERSONAL BEST - 00383730000480 Catalog Number : HS756EU-CEG

Device Description : PERSONAL BEST LR PFM (756EU)-CEG

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

OptiChamber Diamond - 00383730000497 Catalog Number : 1103005

Device Description : DIAMOND-PREFERRED PLUS

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : NVP

Prescription Use : Yes

Device Count : 1

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