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510(k) Data Aggregation
K Number
K060851Device Name
SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER
Manufacturer
THE SMITHWORKS COMPANY
Date Cleared
2006-12-22
(269 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
THE SMITHWORKS COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Soft Sack iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.
The FloorMount iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.
The Pak 2 iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.
The Thermal Sack Pressure Infuser is a thermal maintenance device. It is intended for use as an accessory for use with iv fluid warmer devices to enhance the ability to deliver thermal normal iv fluids in the field, by insulating the bag and tubing. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in clinical and field environments. This device has not been tested for pediatric use.
Device Description
Each of the iv fluid warmer devices (Soft Pack, FloorMount and Pak 2) employs a heating plate or heating blanket to warm or maintain the temperature of iv fluids such as normal saline and ringers lactate. These devices use a standard temperature control method and operate reliably in the range of 36-38 degrees C. The Smithworks products are designed to use a 40 watt, 12 VDC with an optional 120 VAC adaptor, for enhanced safety and portability when used in the field.
The Thermal Sack Pressure Infuser is an accessory to the Smithworks iv fluid warmer components. This device is wrapped around the iv fluid bag and is used to apply even pressure to the iv fluid bag when it cannot be maintained in the standard hanging state, which applies normal gravity pressure. This device should only be used in conditions that require emergency personnel to move victims in conditions that prevent a normal gravity based suspension of the iv fluid bag, and when the rescue mission is conducted by a limited number of emergency medical personnel.
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