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Organization name
UDI-DI code
Reference / catalog number

40020 — Class IIb MDD by Venner Medical…

MD Atlas
Venner Medical (Deutschland) GmbH

EUDAMED last updated this device on Apr 8, 2022

40020

B-000005934400202A

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Venner Medical (Deutschland) GmbH
UDI-DI code: D-000005934400202A
Reference / catalog number: 40020

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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
Lesen Sie die Gebrauchsanweisung vor Inbetriebnahme und beachten Sie unbedingt die Sicherheitshinweise.
CW011
Setzen Sie PEGA® PCA 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 2 countries total.

Country	On market since	Until
GermanyPrimary placement	May 26, 2009	Mar 31, 2019
Austria	Jan 31, 2009	Mar 31, 2019

Device identification

Trade name: not provided
UDI-DI code: D-000005934400202A
Basic UDI-DI: B-000005934400202A
Reference / catalog number: 40020
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® PCA is a portable, volumetric micro infusion pump for the parenteral administration of drugs in ambulatory and in-patient infusion therapies. It can be used for all types of administration, both for PCA therapy and for continuous infusions.
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.