RoweEpiflow

Organization name

RoweMed AG - Medical 4 Life

SRN

DE-MF-000005350

Manufacturer status

Active

14 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

  Note the burst pressure information on the packaging!
• CW999

  Blocked filter must not be flushed! This can cause damage to the membrane and prevented contamination can scoured out. Blocked filter must be removed and replaced. The blocking of the filter is an indication of contamination or incompatibility of drugs. Supplementary injections can lead to high pressure on the filter area. That can lead to damage of the membrane. Attention: In this case, please use special filter-systems with injection port.
• CW999

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

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

  The instructions for use of the manufacturer of the drug or syringe pump used must also be taken into account.
• CW999

  The filter does not have a vent filter!
• CW999

  The maximum application times must be complied with.

Primary placement in Germany; available across 1 country total.

Trade name

RoweEpiflow

UDI-DI code

04250347603969

Basic UDI-DI

42503476EPIFLOWKE

Reference / catalog number

A-6704

Issuing entity

GS1

Risk category

Class IIa

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.

• A04010101WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS)

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