116163010

Nom de l'organisation

Bactiguard AB

SRN

SE-MF-000020790

Statut du fabricant

Actif

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

• CW999

  Under the following conditions the use of the device should be avoided, unless justified by the treating physician: For urethral catheterization: ● Trauma of urethra or bladder ● Acute prostatitis
• CW999

  Under the following conditions the use of the device should be avoided, unless justified by the treating physician: For suprapubic catheterization: ● Known or suspected carcinoma of the bladder ● Absence of an easily palpable or ultrasonographically localized distended urinary bladder ● Previous lower abdominal surgery ● Coagulopathy (until the abnormality is corrected) ● Ascites ● Prosthetic devices in lower abdomen (e.g., hernia mesh)

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

07333330104050

Basic UDI-DI

7333330FOLEYSIL120101ZR

Numéro de référence/catalogue

116163010

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

The BIP Foley Catheter - Silicone are silicone Foley catheters. The catheter body has the benefit of the Bactiguard® coating, applied both on the inside and the outside. The coating consists of a noble metal alloy that reduces microbial adhesion to the catheter surface. To increase patient comfort, the catheter also has a hydrophilic coating that provide excellent lubrication. The BIP Foley Catheter -Silicone is tissue friendly.

URL des informations complémentaires

https://www.bactiguard.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• U010299URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER

Santé des certificats sur le portefeuille de ce fabricant.