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) (5) Holding chambers, direct patient interface (NVP) (3) SPIROMETER, THERAPEUTIC (INCENTIVE) (BWF) (2)

Premarket Exempt

No Yes

Clear

THRESHOLD - 00383730000121 Catalog Number : HS730

Device Description : Threshold IMT Assesmbly

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

THRESHOLD - 00383730000138 Catalog Number : HS735

Device Description : Threshold Pep Assembly

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

OptiChamber Diamond - 00383730000145 Catalog Number : 1097502

Device Description : OptiChamber Diamond Anti-Static Valved Holding Chamber

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : NVP

Prescription Use : Yes

Device Count : 1

InnoSpire Go Handset and Mouthpiece - 00383730000169 Catalog Number : 1126698

Device Description : InnoSpire Go Handset and Mouthpiece Assembly

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

OPTICHAMBER DIAMOND - 00383730000176 Catalog Number : 1077478

Device Description : OPTICHAMBER DIAMOND - 10 PACK

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : NVP

Prescription Use : Yes

Device Count : 1

OPTICHAMBER DIAMOND - 00383730000183 Catalog Number : 1079820

Device Description : OPTICHAMBER DIAMOND - ROW

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : NVP

Prescription Use : No

Device Count : 1

OPTICHAMBER DIAMOND - 00383730000190 Catalog Number : 1079822

Device Description : OPTICHAMBER DIAMOND W SMALL MASK- ROW

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

OptiChamber Diamond - 00383730000206 Catalog Number : 1079823

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

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

OPTICHAMBER DIAMOND - 00383730000213 Catalog Number : 1079825

Device Description : OPTICHAMBER DIAMOND W MED MSK- ROW

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

OptiChamber Diamond - 00383730000220 Catalog Number : 1079826

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

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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