30425000098

Trade name

not provided

UDI-DI code

05412977000252

Basic UDI-DI

5412977AconcentratePK

Reference / catalog number

30425000098

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Solhemo is a liquid acid concentrate in multiple formulations intended to create: • dialysis solution for haemodialysis (HD) and haemodiafiltration (HDF) and • substitution fluid for haemofiltration (HF) and haemodiafiltration (HDF). All three techniques, Haemodialysis (HD), Haemofiltration (HF) and Haemodiafiltration (HDF) use the filtration of blood across a semi-permeable membrane into another fluid.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• F040101DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE

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

• CW007

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW011

  Acid concentrate to be used in extracorporeal bicarbonate-based haemodialysis, haemodiafiltration or haemofiltration, for patients suffering from acute or chronic renal failure. Acid concentrate intended to be used as one component in the preparation of dialysate in a three-stream proportioning haemodialysis machine. Check conductivity and where applicable pH of the final dialysate prior to dialysis treatment, in line with the haemodialysis machine manufacturer’s instructions. Dilute acid concentrate with water meeting the requirements of ISO 23500-3. Sodium bicarbonate is to be added before use. Do not over mix with bicarbonate concentrate. Dilute acid concentrate immediately before use. Refer to the haemodialysis machine manufacturer’s instructions for mixing of dialysate. Consider all sources of buffer including the bicarbonate concentrate and the acetate and/or citrate in the acid concentrate. Do not use for intravenous infusion. Dispose unused concentrate in accordance with local regulations.

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