Eight Medical International B.V.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Warmer, Thermal, Infusion Fluid (LGZ) (2)

Premarket Exempt

Clear

Recirculator - 08719992086009 Catalog Number :

Device Description : The Recirculator 8.0 is comprised of two components: a portable control consol The Recirculator 8.0 is comprised of two components: a portable control console and a single use disposable. The Console consists of a heater, pump, user touch screen, microprocessor, and interface electronics.The primary user interface is a color touch screen display that allows the user to make selections from the operating screen consisting of message display area, main screen area and flow control area. The touch screen also displays operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, alarm and status messages, various timers and auxiliary temperatures. The Recirculator 8.0 monitors various sensors in the fluid path to ensure safe operation and alerts the user with alarms for out of specification conditions. Independent protection circuits prevent unsafe operation in the event of system software fault.The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.

Device Class : 2

Duns Number: 490348632

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Lavage Procedure Kit - 08719992086016 Catalog Number :

Device Description : The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannula The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.