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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

30020 — Class IIb MDD by Venner Medical…

MD Atlas
Venner Medical (Deutschland) GmbH

EUDAMED last updated this device on Apr 8, 2022

30020

B-00000593430020ZU

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Venner Medical (Deutschland) GmbH
UDI-DI code: D-00000593430020ZU
Reference / catalog number: 30020

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Manufacturer information

Organization name: Venner Medical (Deutschland) GmbH
SRN: DE-MF-000005934
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
Diese Gebrauchsanweisung (GA) ist nur für eingewiesenes Fachpersonal bestimmt. Lesen Sie die GA vor Inbetriebnahme und beachten Sie unbedingt die Sicherheitshinweise.
CW011
Setzen Sie PEGA® plus nicht für die Applikation von Arzneimitteln ein, bei der eine Unterbrechung der Infusion zu einer lebensbedrohlichen Situation führen kann.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Sep 1, 2004	Dec 31, 2010

Device identification

Trade name: not provided
UDI-DI code: D-00000593430020ZU
Basic UDI-DI: B-00000593430020ZU
Reference / catalog number: 30020
Issuing entity: EUDAMED

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: PEGA® plus ist eine tragbare volumetrische Mikroinfusionspumpe zur parenteralen Applikation von Arzneimitteln bei ambulanten und stationären Infusionstherapien. Sie kann für alle Applikationsarten, sowohl für PCA-Therapie als auch für kontinuierliche Infusionen, eingesetzt werden.
Additional information URL: https://www.vennermedical.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030301INFUSION PUMPS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.