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510(k) Data Aggregation
K Number
K213191Device Name
S-Line
Manufacturer
Barkey GmbH & Co. KG
Date Cleared
2022-05-24
(237 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
**Barkey GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barkey S-Line blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients. It delivers the fluid via intravenous (IV) administration in hospitals and clinical settings where warmed intravenous fluids are required.
Device Description
The Barkey S-line is a blood and infusion fluid warmer. The infused fluid flows through a standard IV set. The IV line is inserted into a groove in a warming sleeve, referred to as the Sline. The warming sleeve is made of silicon with embedded heating wires. There is no direct contact between the heat exchanging tube and the fluids. The fluid only contacts the off-the-shelf 510(k) I.V. extension set. There is no software / firmware in the device. The S-line operates on 100 - 240 VAC. 50/60 Hz powering an IEC 60601-1 compliant internal power supply. The set temperature is set to 39 ℃ which is not user selectable. The fluid is warmed to approximately 39 ℃ as it travels a path through the heating sleeve. The temperature is constantly monitored and adjusted. The temperature is measured at the end of the extension set, where it leaves the heated sleeve prior to delivery to the patient. The S-line unit weighs approximately 1.3 kg and is equipped with a knob clamp at the back of the devices for attachment to an I.V. pole, the S-line may also be clamped to a bedrail. Independent overtemperature protector monitors the temperature in the warming section. In case of a fault, there is a second overtemperature safety feature which if a temperature of 43°C +/- 1°C is reached, the warming section's heater is switched off, the luminous ring in the display and control panel shows yellow and an acoustic alarm sounds.
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K Number
K071909Device Name
PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R
Manufacturer
BARKEY GMBH & CO. KG
Date Cleared
2007-10-18
(99 days)
Product Code
KOC
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
**BARKEY GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat loss to the atmosphere and effluent flow during a Prismaflex® treatment.
Device Description
The Prismacomfort blood warmer consists of one controller and one sleeve warmer. The controller (Barkey autocontrol 3XPT) controls the sleeve warmer (Barkey autoline XPT 4R) and displays alarm and status messages. The Prismacomfort blood warmer warms the returning blood flow line by means of a silicon tube heat exchanger (applied part Barkey autoline XPT 4R) which covers the blood return flow line of the Gambro Prismaflex® system completely. The heat is transferred by the contact of the resistance heating system Barkey autoline XPT 4R to the inserted blood return line. The complete enclosure of the returning blood flow line to be warmed ensures that there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the return blood flow at maximum efficiency. The device is intended for the Prismaflex® System and may be used with any of the Prismaflex® system therapy choices, when heat loss may cause undesirable cooling of the patient.
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