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510(k) Data Aggregation
K Number
K101532Device Name
NESSI OTC SPACER
Manufacturer
PHARMACARIBE
Date Cleared
2010-09-01
(90 days)
Product Code
NVO
Regulation Number
868.5630Why did this record match?
Product Code :
NVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NESSI OTC Spacer is intended to be used to administer aerosolized medication from pressurized Metered-Dose Inhalers, which are over-the-counter (OTC), e.g., bronchodilator / epinephrine.
Device Description
The NESSI is a spacer intended for use in the inhalations which are provided by OTC MDIs. The device consists of a translucent housing a back piece and mouth piece or face mask. It is a single patient, multi-use device.
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K Number
K091862Device Name
NESSI SPACER
Manufacturer
PHARMACARIBE
Date Cleared
2009-11-20
(150 days)
Product Code
NVO
Regulation Number
868.5630Why did this record match?
Product Code :
NVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NESSI Spacer is intended to be used by patients who are under the care of treatment of a licensed healthcare professional or physician. The device is intended to be used by these patients to administer aerosolized medication from pressurized Metered-Dose Inhalers, prescribed by a physician or healthcare professional.
Device Description
The NESSI is a spacer intended for use in the inhalation of MDIs for the therapy of the upper and lower respiratory system. The device consists of a translucent housing a back piece and mouth piece.
The NESSI Spacer can be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances:
- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and ß2-sympathomimetics (bronchodilater medications)
- · Non-steroidal chromones (DNCG)
It is a single patient, multi-use device.
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