NEOPRENE ICE PACK BAND

Organization name

PHYTO PERFORMANCE ITALIA SRL

SRN

IT-MF-000008118

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Neoprene may cause allergic reactions of the skin. If rash develops discontinue use and consult a physician. In case of circulatory problems use it under medical supervision. Do not use the band while sleeping. To be used under adult supervision for minors under 14 years of age.

Primary placement in Italy; available across 1 country total.

Trade name

NEOPRENE ICE PACK BAND

UDI-DI code

08031255014001

Basic UDI-DI

80312550009K4

Reference / catalog number

P406.1

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

holding the ice-bag in an autonomous manner without using the hands. The packaging contains the neoprene band. How to apply: 1 - insert the lid in the hole 2 - place on the interested area. 3 - adjust with the straps for a comfortable fit. Washing instructions: After each use, wash by hand or in the washing machine at 30°C with soap or neutral detergent. Allow to dry completely. Do not tumble dry or iron. 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.

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.

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER