Organization name

B. Braun Avitum AG

SRN

DE-MF-000005127

Manufacturer status

Active

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

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

Primary placement in Germany; available across 27 countries total.

Trade name

B.Braun

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.

04046955642014

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.

403923900000191938

Reference / catalog number

7211048DF

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

ACIDIC HD CONC. SW 466A BAG 3,8L (1+44)

Additional information URL

https://eifu.bbraun.com/

Clinical sizes

• 2 MPL
• 1.5 MPL
• 0.5 MPL
• 3 MPL
• 32 MPL
• 1 GLI
• 138 MPL
• 109 MPL

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

• 04046955642014× 1 unitBase unit
  • 04046955642021× 3 units

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

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

• F040101DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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