VECTURA GROUP PLC

Address:1-4 Prospect West,Chippenham Wiltshire,GB

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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) (10)

Premarket Exempt

Clear

FOX MOBILE - 05056143200000 Catalog Number : 08CD0002

Device Description : The Nebuliser Mouthpiece is part of the FOX MOBILE Inhalation Set.

Device Class : 2

Duns Number: 536137748

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

FOX MOBILE - 05056143200017 Catalog Number : 08RS2000

Device Description : The FOX MOBILE Nebulizer Head is part of the FOX MOBILE Inhalation Set.

Device Class : 2

Duns Number: 536137748

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

FOX MOBILE - 05056143200024 Catalog Number : 08RS5000

Device Description : The FOX MOBILE Base Unit is part of the FOX MOBILE Inhalation System.

Device Class :

Duns Number: 536137748

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

FOX MOBILE - 05056143200031 Catalog Number : 08CD0010

Device Description : The FOX MOBILE Inhalation System consists of following components: base unit, ch The FOX MOBILE Inhalation System consists of following components: base unit, charger, Inhalation set, carry case, instructions for use.

Device Class :

Duns Number: 536137748

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

FOX MOBILE - 05056143200055 Catalog Number : 08CD0025

Device Description : The FOX MOBILE Inhalation Set (US) is part of the FOX MOBILE Inhalation System ( The FOX MOBILE Inhalation Set (US) is part of the FOX MOBILE Inhalation System (US) and consists of following components: Nebulizer head, nebulizer mouthpiece and instructions for use (for FOX MOBILE Inhalation Set).

Device Class :

Duns Number: 536137748

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

N/A - 05056143200093 Catalog Number : 01VB0100

Device Description : Nebuliser handset in printed polyethylene bag

Device Class : 2

Duns Number: 536137748

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

N/A - 05056143200109 Catalog Number : N/A

Device Description : Set of 10 nebuliser Sets

Device Class : 2

Duns Number: 536137748

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

N/A - 05056143200116 Catalog Number : N/A

Device Description : Set of 5 Bulk Pack in one shipment box

Device Class : 2

Duns Number: 536137748

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

N/A - 05056143200123 Catalog Number : 01VB0103

Device Description : AKITA JET Nebulizer Tube System

Device Class : 2

Duns Number: 536137748

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

AKITA JET - 05056143200154 Catalog Number : 01RS0100

Device Description : The Akita Jet Device is a breath actuated jet nebuliser with active flow and vol The Akita Jet Device is a breath actuated jet nebuliser with active flow and volume control to ensure precise drug dosing and targeting. It is intended only on conscious, cooperative adults and children with severe asthma. It is designed for temporary oral inhalation of the aerosol created by the device. The system is intended for single patient use.

Device Class : 2

Duns Number: 536137748

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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