070302002

Nom de l'organisation

IEM GmbH

SRN

DE-MF-000005735

Statut du fabricant

Actif

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

• CW999

  Risk of strangulation due to shoulder strap and cuff tube!
• CW999

  Lymph congestion due to inflation of the cuff!
• CW999

  Allergic reactions due to the cuff material!
• CW999

  Risk of injury due to incorrectly connected air tube!
• CW999

  Increased electromagnetic emissions/reduced electromagnetic immunity of the device due to the use of non-approved accessories!
• CW999

  Misdiagnosis due to incorrect measurements in patients with white coat hypertension!
• CW999

  Self-diagnosis by the patient
• CW999

  Incorrect or inaccurate measurement results due to an incorrectly positioned cuff
• CW999

  Circulation problems due to constant cuff pressure or due to measurements performed too often
• CW999

  Danger of a temporary loss of function of a present electrical medical device as a result of putting on or pumping up a cuff if you are wearing a further electrical medical device for monitoring on the same limb.
• CW999

  Risk of injury when applying and inflating a cuff over a wound!
• CW999

  Danger of blood flow disruptions as a result of putting on and pumping up a cuff on limbs with an intravascular drip or intra-vascular treatment or with an arteriovenous (AV) shunt.
• CW999

  Risk of injury due to internal bleeding in the tissue or hematoma!
• CW999

  Risk of injury due to positioning and inflating a cuff on an arm on the side of the body where there has been a mastectomy!

Marché principal en Allemagne ; disponible dans 19 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

04041346102405

Basic UDI-DI

B-04041346102405

Numéro de référence/catalogue

070302002

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12050404BLOOD PRESSURE HOLTER RECORDERS

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