Search Results
Found 2 results
510(k) Data Aggregation
K Number
K192325Device Name
Quantum Blood and Fluid Warming System
Manufacturer
Life Warmer, Inc.
Date Cleared
2019-10-18
(52 days)
Product Code
LGZ, BSB, LZG
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Life Warmer, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum" Blood and Fluid Warming System is indicated for warming blood, blood products and intravenous solutions prior to administration in adult and pediatic patients greater than 28 days old of normal birth weight. It is intended for use by healthcare professionals in hospital, clinical, field, and transport environments to help prevent hypothermia.
The Quantum is not for use with neonates (birth to 28 days old) or infants of low birth weight.
Device Description
The Quantum Blood and Fluid Warming System is a light weight, portable, battery powered, in-line fluid warming system in which specially designed thermal IV administration tubing is integrated with a warming element. The device is prescription only. The Quantum is comprised of the following components: Controller, Battery, Charger, and Quantum thermal tubing available in two configurations: TIS (Thermal Infusion Set) and TTS-B (Thermal Transfusion Set for blood) with standard IV administration components. The microprocessor and algorithm in the Quantum Controller continually receive and assess temperature input from thermistors located on the tubing segments. In response to this input, the Controller regulates the energy applied to the tubing to reach and/or maintain a pre-set temperature range of 38 °C ± 2 °C at delivery. A double-extrusion process results in tubing configuration with an inner tubing layer and an outer tubing laver. The warming element is in between but does not contact the fluid. Warming begins at the fluid source and continues the length of the tubing until near the point of patient entry. The TIS an TTS-B tubing perform the same function as standard IV tubing, however, when warming is desired, the TIS or TTS-B is simply connected to the Quantum Controller is connected to the Battery. The TIS and TTS-B tubing sets are provided sterile (i.e., fluid path) for single patient use. The Controller, Battery and Battery Chargers are reusable.
Ask a Question
K Number
K181775Device Name
Quantum Blood and IV Fluid Infusion Warmer
Manufacturer
Life Warmer, Inc.
Date Cleared
2019-01-28
(209 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Life Warmer, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum Blood and IV Fluid Infusion Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration in adult patients. It is intended to be used by healthcare professionals in hospital. clinical. field and transport environments to help prevent hypothenmia.
Device Description
The Quantum Blood and IV Fluid Infusion Warmer is a light weight, portable, battery powered, in-line fluid warming system in which specially designed thermal IV administration tubing is integrated with a warming element. The device is prescription only. The Quantum is comprised of the following components: Controller, Battery, Charger, and Quantum thermal tubing available in two configurations: TIS (Thermal Infusion Set) and TTS-B (Thermal Transfusion Set for blood) with standard IV administration components. The microprocessor and algorithm in the Quantum Controller continually receive and assess temperature input from thermistors located on the proximal, medial and distal tubing segments. In response to this input, the Controller regulates the energy applied to the tubing to reach and/or maintain a pre-set temperature range of 38 °C ± 2 °C at delivery. A double-extrusion process results in tubing configuration with an inner tubing layer and an outer tubing layer. The warming element is in between but does not contact the fluid. Warming begins at the fluid source and continues the length of the tubing until near the point of patient entry. The TIS an TTS-B tubing perform the same function as standard IV tubing, however, when warming is desired, the TIS or TTS-B is simply connected to the Quantum Controller and the Controller is connected to the Battery. The TIS and TTS-B tubing sets are provided sterile (i.e., fluid path) for single patient use. The Controller, Battery Chargers are reusable.
Ask a Question
Page 1 of 1