MD002

Organization name

TCC GmbH

SRN

DE-MF-000036584

Manufacturer status

Active

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• CW010

  Contraindications: It is specifically designed for adult (older than 18 years of age). The MD is not intended for use in patients with previously recorded renal replacement therapy or receiving medication that effects the relevant vital signs. Patients with previously diagnosed AKI are also excluded.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04262435350013

Basic UDI-DI

426243535MD002XN

Reference / catalog number

MD002

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

AKI Prediction Service is a backend service of an algorithm of a clinical flag intended to predict an adult‘s probability of developing an acute kidney failure. The backend service can be called via an open API from any calling platform, by transmitting all necessary input data. It returns a risk label and color code to the calling plattform. There is no direct user-interaction with this service.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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