1250.1

Organization name

FARMABAN s.a.

SRN

ES-MF-000004713

Manufacturer status

Active

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• CW999

  CONTRAINDICATIONS • Decompensated heart insufficiency • Septic phlebitis • Advanced diabetic microangiopathy • Phlegmasia coerulea dolens • Severe arterial occlusive disease in patients with an ankle-branchial pressure index (ABPI) of less than 0.6 • Known hypersensitivity to any of the materials of the components PRECAUTIONS AND GENERAL CONSIDERATIONS Always apply under the supervision of a healthcare professional. It is recommended to have an adequate training for the correct application of the compression system. Check that the patient’s ABPI is higher than 0.6 before applying the compression system Patients with known arterial insufficiency, decompensated heart insufficiency, or advanced diabetic microangiopathy may not tolerate compression; it should only be used under medical prescription, with careful monitoring and after appropriate treatment. Wrapping too tightly may impair circulation. Monitor the area of application frequently for signs of discolouration, pain, numbness, tingling or other changes in sensation and swelling. If these symptoms appear, patients should remove the bandage immediately and inform the healthcare professional. If the patient does not initially tolerate full compression, the cohesive bandage can also be applied with less tension leading to less compression. Before applying, it is necessary to perform the usual diagnostic examinations. Wounds must be cleansed and covered with wound dressings appropriate to the wound conditions. Follow current national guidelines and local regulations for infections control. If the compression system becomes wet, loose fitting or when it no longer conforms to the shape of the bandaged area it should be replaced. Do not reuse. Reuse can compromise product integrity or lead to device failure. Any serious incident related to the product must be reported to the manufacturer and to the competent authority of the Member State in which the user and/or patient are established

Primary placement in Spain; available across 1 country total.

Trade name

not provided

UDI-DI code

08428012125016

Basic UDI-DI

8428012COMPRESION2LRZ

Reference / catalog number

1250.1

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

2-layer compression system

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 10 MU10
• 5.5 MU36
• 18–25 MU10
• 20 MU51

• M03040199ELASTIC COMPRESSION BANDAGES - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification