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Found 5 results
510(k) Data Aggregation
K Number
K211800Device Name
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
Manufacturer
Quality in Flow Ltd.
Date Cleared
2022-12-08
(546 days)
Product Code
LGZ, BSB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Quality in Flow Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Warrior Blood and Fluid Warmer device is intended for warming blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.
The Warrior EXTREME Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.
The Warrior Lite Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.
Device Description
The QinFlow Blood and Fluid Warmer (Warrior / Warrior lite) is a portable sterile fluid path, inline blood and fluid warmer intended for warming blood, blood products, and intravenous fluids prior to administration. The device is composed of the following main components:
1. Disposable Unit (DU) / Compact Disposable Unit (CDU)
2. Base Unit (BU)
3. Power source
4. Connecting Cable (CC)
5. The CDU can be connected directly onto the Warrior Lite BU or using an Extension cable accessory. The DU can be connected to the Warrior Lite using the Extension cable only.
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K Number
K180154Device Name
QiF Blood and Fluid Warmer
Manufacturer
Quality In Flow Ltd.
Date Cleared
2018-04-27
(98 days)
Product Code
LGZ, BSB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Quality In Flow Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics, and field environments, to help prevent hypothermia.
Device Description
The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components:
1. Disposable Unit (DU) - The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors.
2. Base Unit (BU) – The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU or an AC power supply module; the BU contains firmware (SW) and electronics (HW).
3. Connecting Cable (CC) - a cable that connect between the BU and the DU to facilitate the transfer of data and electrical current.
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K Number
K171215Device Name
QiF Blood and Fluid Warmer
Manufacturer
Quality In Flow Ltd.
Date Cleared
2017-09-27
(155 days)
Product Code
LGZ, BSB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Quality In Flow Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospitals, clinics and field environments, to help prevent hypothermia.
Device Description
The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components: 1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors. 2. Base Unit (BU) The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU: the BU contains firmware (SW) and electronics (HW). 3. Connecting Cable (CC) a cable consisting of data and power wires connects between the BU and the DU to facilitate the transfer of data and electrical current.
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K Number
K163708Device Name
QiF Blood and Fluid Warmer
Manufacturer
Quality In Flow Ltd.
Date Cleared
2017-04-20
(112 days)
Product Code
LGZ, BSB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Quality In Flow Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics and field environments, to help prevent hypothermia.
Device Description
The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components: 1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The Disposable Unit is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The Disposable Unit has a standard intravenous tube extension. The Disposable Unit comprises the temperature sensors. 2. Base Unit (BU) The Base Unit controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the Base Unit; the Base Unit contains firmware (SW) and electronics (HW). 3. Connecting Cable (CC) - a cable consisting data and power wires connects between the Base Unit and the Disposable Unit to facilitate the transfer of data and electrical current.
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K Number
K150404Device Name
QiF Blood and Fluid Warmer
Manufacturer
Quality in Flow Ltd.
Date Cleared
2016-06-23
(491 days)
Product Code
LGZ, BSB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Quality in Flow Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics and field environments, to help prevent hypothermia.
Device Description
The Quality in Flow Ltd. QiF Blood and Fluid Warmer device is a portable, sterile Fluid Path, in-line Blood and Fluid Warmer. The device is comprised of a Base Unit and a sterile disposable cartridge (Disposable Unit). The device is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient's body. The Disposable Unit is composed of a plastic oval box encasing a spiral stainless steel heat exchanger tube. The Base Unit contains Firmware (software) and electronics (HW). The base Unit controls the performance of the system and the fluid outflow temperature. The power source is a rechargeable detachable battery located within the Base Unit. The disposable unit cartridge (blood/fluid) is provided with inlet and outlet luers that connect to standard IV tubing.
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