TCM-21V

Organization name

EM-MED Spółka z ograniczoną odpowiedzialnością spółka komandytowa

SRN

PL-MF-000004822

Manufacturer status

Active

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

• CW010

  Read the user manual before use
• CW008

  After therapy make sure that water has been removed from the blanket
• CW027

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

  Thermotherapy pads and blankets should not be used for patients with visible, serious skin damage.

Primary placement in Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Trade name

not provided

UDI-DI code

05907222570210

Basic UDI-DI

5907222BLT9

Reference / catalog number

TCM-21V

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

Multiple use blankets/pads for temperature therapy through which there is a water flow when the blankets are connected to a device that pumps water into the blankets. The blanket pads are non-invasive and work through conduction with intact skin. It is intended for use in a healthcare facility environment by professional users, in temperature management.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Small

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

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

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER