Organization name

B. Braun Melsungen AG

SRN

DE-MF-000000201

Manufacturer status

Active

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

• Do not use if package is damaged
• Do not use past indicated date
• Do not re-use

Primary placement in Germany; available across 27 countries total.

Trade name

Omnifix® Luer Duo

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.

04022495251565

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.

403923900000077633

Reference / catalog number

4643119V

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

OMNIFIX 5 ML DUO 22GX1 1/4"

Additional information URL

https://eifu.bbraun.com/

Clinical sizes

• 22
• 5 ML

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

• 04022495251565× 1 unitBase unit
  • 04022495251572× 100 units
    • 04022495251589× 20 units

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

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

• A020102010201INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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