Organization name

The Surgical Company International B.V.

SRN

NL-MF-000001973

Manufacturer status

Active

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• check the User Manual

  OTHER

Primary placement in Netherlands; available across 31 countries total.

Trade name

Fluido® Trauma 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.

18719867001714

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.

8719867EMDNZ12030385FRK

Reference / catalog number

671500

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.

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.

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Fluido® Trauma Set is a Y-type administration set with two spikes and is used for flow rates of 20 to 800 ml/min (free flow). This set contains a deaeration chamber and non-return valve, administration point and filter. The set is connected to the patient through a patient line, which is included in the set.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

2 packaging levels registered — each level carries its own UDI-DI.

• 18719867001714× 1 unitBase unit
  • 18719867001721× 15 units
    • 18719867001738× 2 units

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• Z12030385INFUSION INSTRUMENTS - CONSUMABLES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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