Solhemo

Nom de l'organisation

Sterima

SRN

BE-MF-000017855

Statut du fabricant

Actif

3 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW010

  EUDAMED n'a pas publié de description pour ce 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.
• CW007

  EUDAMED n'a pas publié de description pour ce code.

Marché principal en Belgique ; disponible dans 2 pays au total.

Dénomination commerciale

Solhemo

Code d'UDI-DI

05412977000986

Basic UDI-DI

5412977AconcentratePK

Numéro de référence/catalogue

30425000095

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• F040101DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE

Santé des certificats sur le portefeuille de ce fabricant.