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

MASK, OXYGEN (BYG) (7) NEBULIZER (DIRECT PATIENT INTERFACE) (CAF) (2) Compressor, air, portable (BTI) (1)

Premarket Exempt

No Yes

Clear

ISG Handset and Mouthpiece Assy Russia - 00383730004181 Catalog Number : 1134129

Device Description : ISG Handset and Mouthpiece Assy Russia

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Innospire Go - 00383730004204 Catalog Number : 1126586

Device Description : ISG HANDSET AND MOUTHPIECE ASSY KOREA

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

SYSTEM 22 - 00383730004211 Catalog Number : 1055043

Device Description : SYSTEM 22 ADULT AEROSOL MASK ASSEMBLY

Device Class : 1

Duns Number: 220018415

Premarket Exempt : No

Product Code : BYG

Prescription Use : No

Device Count : 1

System 22 - 00383730004235 Catalog Number : 1100A

Device Description : ADULT SYSTEM AEROSOL MASK (EACH)

Device Class : 1

Duns Number: 220018415

Premarket Exempt : No

Product Code : BYG

Prescription Use : No

Device Count : 1

System 22 - 00383730004242 Catalog Number : 1100

Device Description : SYS 22 ADULT MASK-50CS

Device Class : 1

Duns Number: 220018415

Premarket Exempt : No

Product Code : BYG

Prescription Use : No

Device Count : 1

SYSTEM 22 - 00383730004259 Catalog Number : 1050430

Device Description : SYSTEM 22 PEDIATRIC AEROSOL MSK SUB ASSY

Device Class : 1

Duns Number: 220018415

Premarket Exempt : No

Product Code : BYG

Prescription Use : No

Device Count : 1

System 22 - 00383730004266 Catalog Number : 1120A

Device Description : CHILD SYSTEM AEROSOL MASK (EACH)

Device Class : 1

Duns Number: 220018415

Premarket Exempt : No

Product Code : BYG

Prescription Use : No

Device Count : 1

System 22 - 00383730004273 Catalog Number : 1100E

Device Description : ADULT SYSTEM AEROSOL MASK -100CS

Device Class : 1

Duns Number: 220018415

Premarket Exempt : No

Product Code : BYG

Prescription Use : No

Device Count : 1

System 22 - 00383730004280 Catalog Number : 1120

Device Description : SYSTEM 22 SYSTEM MASK PEDIATRIC-50CS

Device Class : 1

Duns Number: 220018415

Premarket Exempt : No

Product Code : BYG

Prescription Use : No

Device Count : 1

CUSTOM ELEGANCE - HEALTH MEDICAL - 00383730004303 Catalog Number : 1135167

Device Class : 2

Duns Number: 220018415

Premarket Exempt : No

Product Code : BTI

Prescription Use : Yes

Device Count : 1

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