Organization name

B. Braun Melsungen AG

SRN

DE-MF-000000201

Manufacturer status

Active

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

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

• Do not use past indicated date
• Do not re-use
• Consult instructions for use
• Do not use if package is damaged
• Caution

Primary placement in Germany; available across 27 countries total.

Trade name

Intrafix® Primeline

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.

04046963323349

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.

403923900000026525

Reference / catalog number

4064008

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

INTRAFIX PRIMELINE,I.S.+S.C.SPINL,185CM

Additional information URL

https://eifu.bbraun.com/

Clinical sizes

No clinical sizes registered for this device.

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

• 04046963323349× 1 unitBase unit
  • 04046963331757× 100 units

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

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

• A03010101INFUSION CONTROLLERS WITH OR W/O AIR INLET

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.