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510(k) Data Aggregation
K Number
K072670Device Name
MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
Manufacturer
PARI INNOVATIVE MANUFACTURERS, INC.
Date Cleared
2007-12-13
(83 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PARI INNOVATIVE MANUFACTURERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The eFlow® is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.
Device Description
The PARI eFlow® Electronic Nebulizer is a small, single-patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device, containing a capped medication cup that can be filled by the user. Power input is provided by either four AA batteries or a DC or AC adapter. Alternate power cords/plugs/adapters allow its use in any country.
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K Number
K072982Device Name
PARI HYDRATE V
Manufacturer
PARI INNOVATIVE MANUFACTURERS, INC.
Date Cleared
2007-11-29
(37 days)
Product Code
BTT
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
PARI INNOVATIVE MANUFACTURERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PARI Hydrate V is intended to warm and add moisture to breathing gases to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases for administration to infant, pediatric, and adult patients. The Hydrate V is intended for use in homes, hospitals, and sub-acute institutions.
Device Description
The Hvdrate V is a Respiratory Gas Humidifier which provides heated evaporated water content to dry breathing gases using Capillary Force Vaporization technology. A breathing circuit is used to deliver the heated and humidified gas to the patient.
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K Number
K070498Device Name
HYPER SAL
Manufacturer
PARI INNOVATIVE MANUFACTURERS, INC.
Date Cleared
2007-04-26
(65 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PARI INNOVATIVE MANUFACTURERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated.
Device Description
The proposed inhaled saline solutions are in 3.5%, 6% and 7% concentrations. They are packaged sterile in 4 ml vials for use as indicated.
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K Number
K070107Device Name
PARI HYDRATE G
Manufacturer
PARI INNOVATIVE MANUFACTURERS, INC.
Date Cleared
2007-02-23
(43 days)
Product Code
BTT
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
PARI INNOVATIVE MANUFACTURERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PARI Hydrate G is designed to warm and add moisture to breathing gases for administration to infant, pediatric, and adult patients. The Hydrate G is intended for use in homes, hospitals, and sub-acute institutions.
Device Description
The Hydrate G is a Respiratory Gas Humidifier which provides heated evaporated water content to dry breathing gases using Capillary Force Vaporization technology. A nasal cannula is used to deliver the heated and humidified gas to the patient.
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K Number
K062158Device Name
LC SPRINT STAR
Manufacturer
PARI INNOVATIVE MANUFACTURERS, INC.
Date Cleared
2006-08-28
(31 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PARI INNOVATIVE MANUFACTURERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LC Sprint Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC Sprint Star is intended for pediatric and adult patients consistent with the indications for the aerosol medication.
Device Description
The LC Sprint Star is a small, single patient use, reusable air-powered nebulizer for the inhalation treatment of aerosolized medications. The device is non-sterile, prescriptionuse only, intended for use in hospital, clinic, or home environments.
LC Sprint Star is a cosmetically and geometrically modified version of the LC Sprint nebulizer currently marketed by PARI. The LC Sprint Star has an inspiratory balve on the top component and an expiratory valve on the mouthpiece, allowing for breathcontrolled aerosol output.
The LC Sprint Star will be available as a stand-alone item or a configuration component containing:
- LC Sprint Star nebulizer (consisting of nebulizer cup, top, and baffle insert) I
- L Mouthpiece
- Oxygen tubing (optional) 트
- 트 Mask (optional)
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K Number
K061381Device Name
LC STAR WITH NASAL ADAPTER
Manufacturer
PARI INNOVATIVE MANUFACTURERS, INC.
Date Cleared
2006-06-02
(15 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PARI INNOVATIVE MANUFACTURERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LC Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The nasal adapter facilitates delivery to the upper airways. The LC Star with nasal adapter is intended for adult and pediatric patients consistent with the indications for aerosol medication.
Device Description
The LC Star reusable nebulizer with nasal adapter is a small, single patient use, reusable air-powered nebulizer for the inhalation treatment of aerosolized medications. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.
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K Number
K060357Device Name
TREK S NEBULIZER COMPRESSOR
Manufacturer
PARI INNOVATIVE MANUFACTURERS, INC.
Date Cleared
2006-04-05
(51 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PARI INNOVATIVE MANUFACTURERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek S is intended for adult and pediatric patients.
Device Description
The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.
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K Number
K060399Device Name
LC SPRINT NEBULIZER
Manufacturer
PARI INNOVATIVE MANUFACTURERS, INC.
Date Cleared
2006-03-02
(15 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PARI INNOVATIVE MANUFACTURERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LC Sprint is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC Sprint is intended for adult and pediatric patients consistent with the indications for the aerosol medication.
Device Description
The LC Sprint is a small, single patient use, reusable air-powered nebulizer for the inhalation treatment of aerosolized medications. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.
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K Number
K033833Device Name
EFLOW ELECTRONIC INHALER/NEBULIZER
Manufacturer
PARI INNOVATIVE MANUFACTURERS, INC.
Date Cleared
2004-05-05
(147 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PARI INNOVATIVE MANUFACTURERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The eFlow is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.
Device Description
The PARI eFlow™ is a small, single patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device containing a capped medication cup that can be filled by the user. Power input is provided by cither 4 AA batteries, a DC adapter or an AC adapter. Alternate power cords/plugs/adapters allow use in any country.
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K Number
K020944Device Name
VORTEX VALVED HOLDING CHAMBER
Manufacturer
PARI INNOVATIVE MANUFACTURERS, INC.
Date Cleared
2002-05-09
(45 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PARI INNOVATIVE MANUFACTURERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vortex is indicated for use as a spacer/valved holding chamber for use in delivery of aerosol medication with metered dose inhalers.
Device Description
Vortex is a new spacer/holding chamber designed to assist patients using metered dose inhalers (MDI) for aerosolized drug delivery. Vortex may provide enhanced drug delivery, ease of use and ability to clean/disinfect the device.
Vortex is a reusable device consisting of an aluminum cylinder with an elastomeric fitting on one end to accept metered dose inhalers and a valved mouthpiece on the other end to interface with the patient. The elastomeric fitting may be removed for cleaning and/or replacement.
Vortex will be available as a stand-alone item and will also be available packaged with a mask.
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