P200.13

Organization name

PHYTO PERFORMANCE ITALIA SRL

SRN

IT-MF-000008118

Manufacturer status

Active

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

• CW135

  EUDAMED did not publish a description for this code.
• CW307

  EUDAMED did not publish a description for this code.
• CW422

  EUDAMED did not publish a description for this code.
• CW417

  EUDAMED did not publish a description for this code.
• CW999

  Always use a barrier like a cloth or towel between the skin and the pack to prevent burns or frostbite.

Primary placement in Italy; available across 6 countries total.

Trade name

not provided

UDI-DI code

08031255012687

Basic UDI-DI

80312550003JQ

Reference / catalog number

P200.13

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

Cryoflex reusable gel pad – non toxic – soft & flexible – microwaveable – for hot and cold therapies. DIRECTIONS - COLD: store the gel pad in the freezer. To make it cooler down quicker, if the pad is at room temperature, leave it in the freezer for at least 2 hours before use. HOT: Heat the gel pad in a pot with hot water for 10 minutes (max 60°C), or heat in the microwave oven: place it in the microwave safe container and cover it with water at max 350W, max 3 minutes. Cold therapy may be necessary in case of headache, fever, trauma, insect bites, bruises, swelling, toothache. Heat therapy may be necessary in case of muscle pain, neck pain, rheumatic pain and aesthetic treatments. Notice: The user is required to report any incident and/or serious incident that may occur in relation to the device to both the manufacturer and the competent authority of the Member State where the user and/or patient is established. To be used under adult supervision for minors under 14 years of age. Washing instructions for the external cover: after each use, wash by hand/machine in water at 30°C with soap or neutral detergent. Leave to dry adequately. Do not tumble dry. Do not iron. Dispose as per local legislation.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES