Berner UltraSpike SK with metal cannula and 5 µm liquid filter

Organization name

RoweMed AG - Medical 4 Life

SRN

DE-MF-000005350

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW999

  Exclusion of liability: if reprocessed for reuse, the physical, chemical and/or biological product properties may be changed.
• CW999

  This product does not replace the required hygienic and aseptic working practices. Care must be taken to avoid contamination.
• CW999

  If the product is damaged or dropped, do not use it.
• CW999

  If the metal cannula is bent, do not use.
• CW999

  Check the fit of the protective cap before use and discard the product if it has fallen off or is damaged.
• CW999

  The instructions for use of the manufacturer of the medicine used must also be taken into account.

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Trade name

Berner UltraSpike SK with metal cannula and 5 µm liquid filter

UDI-DI code

04250347605239

Basic UDI-DI

42503476SPIKEKY

Reference / catalog number

126212

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• A0704SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS

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