AMSafe® Microbore Extension Set

Trade name

AMSafe® Microbore Extension Set

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

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10704411016267

Basic UDI-DI

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.

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B-10704411016267

Reference / catalog number

AE0112

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

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GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

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Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Intravenous Administration Sets and Accessories is a device used to administer fluids from a container to a patient's vascular system. It has one or more injection site(s) that allow medication injection, without using needles, and thus aids in the elimination of needle-stick injury.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 12 MU28

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

• A03040199INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

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

• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.