EUDAMED last updated this device on May 27, 2026

PEGA® BAG 100 ml

426053749PBAG015A

On the marketClass IIa

Applicable legislation: —
Organization name: Venner Medical (Deutschland) GmbH
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04260537490286
Reference / catalog number: 14100

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

PEGA® BAG 100 ml is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Venner Medical (Deutschland) GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: PEGA® BAG 100 ml
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04260537490286
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 426053749PBAG015A
Reference / catalog number: 14100
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: PEGA® BAG is a medication reservoir equipped with a luer-lock-connection that can be filled with a syringe for parenteral administration of drugs in ambulatory and in-patient infusion therapies. PEGA® BAG is intended for use with the PEGA® Infuse, PEGA® PCA, PEGA® plus and PEGA® light C infusion pumps. PEGA® BAG is connected to the PEGA® infusion pumps through the peristaltic tube which is part of the products PEGA® SET, PEGA® SET curled and PEGA® COMBI LINE E, S, Y. The PEGA® BAG is suitable for intravenous, subcutaneous, epidural, and intrathecal administration of drugs from a PEGA® infusion pump.
Additional information URL: https://www.vennermedical.de/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04260537490286

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A080201INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE

Critical warnings

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

Kontraindikation: Verwenden Sie keine Medikamente, die nicht mit dem Material (PVC) des PEGA® BAG kompatibel sind.
OTHER
Consult instructions for use
Bevor Sie einen PEGA® BAG benutzen, lesen Sie die Gebrauchsanweisung Ihrer PEGA® Pumpe.
Refer to instruction manual/booklet
Beachten Sie auch die Gebrauchsanweisungen von PEGA® COMBI LINE, PEGA® TUBE.
Do not re-use
Dieser Einwegartikel ist zum einmaligen Gebrauch an einem Patienten bestimmt, um eine optimale Funktion und die Hygiene zu gewährleisten. Bei nochmaligem Gebrauch, auch nach Wiederaufbereitung, erlischt die Haftung durch die Venner Medical (Deutschland) GmbH.
Do not use if package is damaged
PEGA® BAGs sind steril verpackt. Verwenden Sie sie nur bei unbeschädigter und ungeöffneter Verpackung.
Während der Therapie darf sich die Pumpe mit dem PEGA® BAG nicht höher als 1 m über dem Herzniveau des Patienten befinden.
OTHER
Das Produkt ist für einen maximalen Druck von 1800 hPa ausgelegt.
OTHER

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Sep 10, 2004	Still on market

PEGA® BAG 100 ml

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

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Manufacturer information

Certificates covering this device

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Certificates