Address:3711 Collins Ferry Road,Morgantown,WV,26505,US
Device Description : The single-use device is in a color coded unit blow fill sealed container with l The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. Thedevice contains no preservative and is sterile and pyrogen free. Primary DI number is for one carton of 100 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.
Device Class : 2
Duns Number: 059295980
Premarket Exempt : No
Prescription Use : Yes
Device Description : The single-use device is in a color coded unit blow fill sealed container with l The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. Thedevice contains no preservative and is sterile and pyrogen free. Primary DI number is for one carton of 100 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.
Device Class : 2
Duns Number: 059295980
Premarket Exempt : No
Prescription Use : Yes
Device Description : The single-use device is in a color coded unit blow fill sealed container with l The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen free. Primary DI number is for one carton of 50 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.
Device Class : 2
Duns Number: 059295980
Premarket Exempt : No
Prescription Use : Yes
Device Description : The 3% solutions are contained in a 15mL polyethylene vial. The vials have a tea The 3% solutions are contained in a 15mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials.Primary DI number is for one carton of 50 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.
Device Class : 2
Duns Number: 059295980
Premarket Exempt : No
Prescription Use : Yes
Device Description : The 10% solutions are contained in a 15mL polyethylene vial. The vials have a te The 10% solutions are contained in a 15mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lotnumber and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied incartons of 50 vials. Primary DI number is for one carton of 50 vials, the lowest saleable unit. Each vial is not sold separately and isnot intended to be separated from it's unit of sale.
Device Class : 2
Duns Number: 059295980
Premarket Exempt : No
Prescription Use : Yes
Device Description : The WhisperJECT autoinjector is a non-sterile injection device. It is intended t The WhisperJECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs.
Device Class :
Duns Number: 059295980
Premarket Exempt : No
Prescription Use : Yes