Organization name

Bluebird Medical AB

SRN

SE-MF-000041371

Manufacturer status

Active

Primary placement in Sweden; available across 32 countries total.

Trade name

Replacement Clamp

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.

07331342000001

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.

7331342RCM03RC

Reference / catalog number

RCM03

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Replacement Clamp is a non-sterile device intended for temporary use to replace a broken clamp on a dialysis catheter without removing the luer lock connector.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• F900299VASCULAR ACCESS DEVICES (ONLY FOR HAEMODIALYSIS) - OTHER

• Class I medical devices in EUDAMED

This device is not currently linked to any other device.

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