Mylan Specialty L.P.

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Device Description : The Aerosol Cloud Enhancer is designed to permit use in a vent circuit, an incep The Aerosol Cloud Enhancer is designed to permit use in a vent circuit, an inceptive spirometer, in conjuction with an endotracheal airway or resuscitation bag and in routine oral inhalation. It has a coneshaped chamber intended to maximize respirable volume. The ACE masks attach and detach easily for MDI delivery.

Device Class : 2

Duns Number: 194775557

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Device Description : Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler (MDI) aerosol medication delivery. It is comprised of a MDI adapter port, Holding chamber, a one way valve, Mouth Piece and mouthpiece cap

Device Class :

Duns Number: 194775557

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Device Description : The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The m The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask is a single piece, injection molded, silicone rubber piece.

Device Class : 2

Duns Number: 194775557

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Device Description : The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The m The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask is a single piece, injection molded, silicone rubber piece.

Device Class :

Duns Number: 194775557

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Device Description : The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The m The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask is a single piece, injection molded, silicone rubber piece.

Device Class :

Duns Number: 194775557

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1