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510(k) Data Aggregation
K Number
K161179Device Name
Intelli-Ox
Manufacturer
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
Date Cleared
2017-04-13
(352 days)
Product Code
ECX
Regulation Number
868.2700Why did this record match?
Applicant Name (Manufacturer) :
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for all other medical applications, the device is Rx only.
Device Description
The Intelli-OX portable oxygen delivery system that supplies Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flow rate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation. Intelli-OX is for emergency use only. For all other medical applications, the device is Rx only. Key specifications include hose barb connection, protective shroud, carrying handle, easy to read content gauge, indexed flow meter, and integrated valve-regulator. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla.
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K Number
K153564Device Name
PURE CRYOGEN
Manufacturer
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
Date Cleared
2016-03-29
(106 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PURE CRYOGEN is indicated to be used as an accessory to Candela Corporation's Dynamic Cooling Device as a source of skin refrigerant fluid. The intended use of PURE CRYOGEN is (1) cooling of the skin prior to laser treatment, (2) reduction of pain during laser treatment, (3) allows for use of higher laser treatments, such as for hair removal and vascular lesions, and (4) reduces potential side effects of laser treatments, such as for hair removal and vascular lesions.
Device Description
Air Liquide's PURE CRYOGEN consists of a disposable, non-refillable cylinder containing 1, 1,1,2-Tetrafluoroethane, commonly referred to as HFC-134a Low NAG gas ("134a gas"). The 134a gas cylinder is intended to be used as an accessory to Candela Corporation's Dynamic Cooling Device™ as a source of skin refrigerant fluid. The cylinder may be inserted into the Dynamic Cooling Device, which is then connected in line with Candela's laser device. Candela's laser controls the delivery of a pulsed spray of 134a gas just prior to the delivery of a laser pulsed spray of skin refrigerant cools the skin as it evaporates. Use of the 134a gas prior to laser treatment minizes thermal damage to skin during laser treatment and reduces pain associated with laser treatment.
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