LM000092

Organization name

LAUDA Medical GmbH & Co. KG

SRN

DE-MF-000027737

Manufacturer status

Active

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• CW999

  Waste Electrical and Electronic Equipment Directive (WEEE Directive 2012/19/EU) Electronic Equipment - DO NOT THROW IT IN TRASH

Primary placement in Norway; available across 4 countries total.

Trade name

not provided

UDI-DI code

04262481810172

Basic UDI-DI

426248181HYPODY

Reference / catalog number

LM000092

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The device HYPO is used to cool/heat and maintain the required temperature of a patient connected to the extracorporeal perfusion circuit (e.g. a heart-lung machine). The temperature is transferred via a heat exchanger (part of the oxygenator) in the patient's perfusion circuit (hypothermia treatment). In addition to hypothermia treatment, the device HYPO can also be used to cool a cardioplegia solution via an additional heat exchanger. The device HYPO is designed for a treatment duration of 6 hours per use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12040208BODY THERMOREGULATION EQUIPMENT

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification