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) (9) Nebulizer (direct patient interface) (CAF) (1) SPIROMETER, THERAPEUTIC (INCENTIVE) (BWF) (1)

Premarket Exempt

No Yes

Clear

ProChamber Assembly - 00383730000718 Catalog Number : HS2003-050

Device Description : PROCHAMBER VHC - 50PK

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BWF, CAF

Prescription Use : Yes

Device Count : 1

LiteTouch - 00383730000725 Catalog Number : 1090814

Device Description : LiteTouch Small Mask Assembly, Polybag

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

LiteTouch - 00383730000732 Catalog Number : 1082714

Device Description : LiteTouch Small Mask, 10-pack.

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

LiteTouch - 00383730000749 Catalog Number : 1083785

Device Description : LiteTouch Small Mask - ROW.

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

LiteTouch - 00383730000756 Catalog Number : 1077183

Device Description : LiteTouch Medium Mask, Packaged

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

LiteTouch - 00383730000763 Catalog Number : 1083784

Device Description : LiteTouch Medium Mask, ROW.

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

LiteTouch - 00383730000770 Catalog Number : 1082715

Device Description : LiteTouch Medium Mask, 10-pack.

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

LiteTouch - 00383730000787 Catalog Number : 1090816

Device Description : LiteTouch Large Mask Assembly, Polybag

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

LiteTouch - 00383730000794 Catalog Number : 1083783

Device Description : LiteTouch Large Mask , ROW.

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

LiteTouch - 00383730000800 Catalog Number : 1082716

Device Description : liteTouch Large Mask, 10 pack.

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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