COOL ROM Knee orthosis-SHORT

Organization name

Orthobroker

SRN

BE-MF-000000331

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW011

  If unusual swelling, skin discoloration or discomfort occurs, use should be discontinued and a healthcare professional consulted. Be careful that the support is not so tigh t that it interferes with circulation. Undertake circulatory observations post-product application. The tension of the straps could be slightly released when in resting position, or at night, to avoid circulatory or nerve compression problems. Ensure appropriate wound care procedures are undertaken prior to application over open wounds or infected areas This device is meant for single patient use.
• CW030

  This brace is to be fitted, initially, by a healthcare professional familiar with the purpose for which it is prescribed. The healthcare professional is responsible for providing guidance to the patient.
• CW010

  This brace should only be applied in accordance with the instructions mentioned in the manual.

Primary placement in Belgium; available across 4 countries total.

Trade name

COOL ROM Knee orthosis-SHORT

UDI-DI code

05404020402069

Basic UDI-DI

5404020402kneehipFJ

Reference / catalog number

12-0023-2

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• brace length= 50 cm

• Y061209KNEE ORTHOSES

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