Organization name

B. Braun Medical AG

SRN

CH-MF-000017781

Manufacturer status

Active

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

• H332 – Harmful if inhaled.
• H317 – May cause an allergic skin reaction.
• H314 – Causes severe skin burns and eye damage.
• H302 – Harmful if swallowed.
• H334 – May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Do not use past indicated date
• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.
• P304 – IF INHALED: P340 – Remove victim to fresh air and keep at rest in a position comfortable for breathing.
• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
• P303 – IF ON SKIN (or hair): P353 – Rinse skin with water/shower.
• P303 – IF ON SKIN (or hair): P361 – Remove/Take off immediately all contaminated clothing.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P273 – Avoid release to the environment.
• P260 – Do not breathe dust/fume/gas/mist/vapours/spray.
• H412 – Harmful to aquatic life with long lasting effects.
• EUH 071 – Corrosive to the respiratory tract.

Primary placement in Germany; available across 27 countries total.

Trade name

Helipur®

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.

07612449016004

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.

40392390000009062Q

Reference / catalog number

3892212

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

HELIPUR H-PLUS-N CANISTER "WEST" 5LT

Additional information URL

https://eifu.bbraun.com/

Clinical sizes

• 5 L

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

• 07612449016004× 1 unitBase unit
  • 07612449016042× 128 units

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

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

• D01010102GLUTARALDEHYDE, ACIDIC SOLUTION FOR THE DISINFECTION OF MEDICAL DEVICES

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.