16010008

Organization name

HILOTHERM GmbH

SRN

DE-MF-000006176

Manufacturer status

Active

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

• CW999

  Apply only to intact skin
• CW999

  Check for leaks before each application
• CW010

  Die Gebrauchsanweisung der Hilotherm Geräte muss beachtet werden.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04250387101852

Basic UDI-DI

42503871MANMMGF

Reference / catalog number

16010008

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

- The cuff may only be used in conjunction with the Hilotherm Calido. - The instruction manual for Hilotherm devices must be observed. - Before each apply the integrity of the cuff must be checked (no blisters, no leakage). Only intact cuffs must be used - The application has immediately to be stopped at the occurrence of abnormalities during treatment such as blistering and leakage - When transporting the cuff, it must be ensured that it is not damaged by sharp objects. - Channel flow in the cuff may be inhibited by creases in the cuff or by pressure. - The operator must monitor the patient’s body temperature at regular intervals. - The cuff may only be applied to intact skin or wound dressings. - Attention: Water can leak out while connecting/disconnecting the cuffs! Hilotherm GmbH Wittumweg 38, D-88260 Argenbühl-Eisenharz, Tel. 07566 91199, www.hilotherapie.com

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 25–27 MU10
• 25–27 MU10

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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