Allmed SafeFlow

Nom de l'organisation

Allmed Medical GmbH

SRN

DE-MF-000007862

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW999

  Contraindications: The utilization of the bacterial and endotoxin filter, manufactured using Polysulfone and PVP, and sterilized by ETO or Gamma and intended to be used for preparation of Ultrapure dialysis fluid and/or online fluid substitution, is contraindicated in individuals with a documented history of hypersensitivity or allergic reactions to any components of the filter, including Polysulfone, PVP, or the sterilization agents ETO and Gamma. Additionally, caution should be exercised in cases where specific contraindications to ETO or Gamma sterilization methods exist for the intended application. Use of the bacterial and endotoxin filter is contraindicated in cases of known hypersensitivity or allergic reactions to Polysulfone, PVP, ethylene oxide (ETO), or Gamma sterilization. Relative contraindications (individual Benefit/Risk to be determined by treating physician) for the use of SafeFlow include: Patients with known hypersensitivity to any of the materials used must not be treated with this product.

Marché principal en EL ; disponible dans 1 pays au total.

Dénomination commerciale

Allmed SafeFlow

Code d'UDI-DI

04260157725263

Basic UDI-DI

426015772SAFEFLOWEOXQ

Numéro de référence/catalogue

SFL 14

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Allmed SafeFlow, is intended to be used for the purification of final dialysate solution to prepare ultrapure dialysis fluid, or the on-line preparation of sterile substitution fluid (in combination with an additional filter; It may perform secondary safety filtering to prepare on-line substitution solution that can be infused into the patient to compensate for loss of fluid volume resulting from haemodialysis). Purification is achieved through the high bacterial and endotoxin retention capabilities of the filter. Ethylene oxide (EO) sterilized, suitable for connection with B. Braun B.Dialog and B.Dialog+ machine

URL des informations complémentaires

https://allmedgroup.com/e-ifu-repository/

Dimensions cliniques

• 1.4 MU85

• F01080201ENDOTOXIN REMOVAL FILTERS

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