101-2000

Organization name

ThermaSolutions Europe BV

SRN

NL-MF-000022782

Manufacturer status

Active

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

• CW016

  EUDAMED did not publish a description for this code.
• CW018

  ThermoChem HT-2000 Operators Manual

Primary placement in Netherlands; available across 9 countries total.

Trade name

not provided

UDI-DI code

00851450007008

Basic UDI-DI

B-00851450007008

Reference / catalog number

101-2000

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The ThermoChem™ HT-2000 raises the temperature in the peritoneal cavity by continuously lavaging the peritoneal cavity with heated solution. The ThermoChem™ HT-2000 continually circulates heated perfusate throughout the cavity, accurately raising tissue temperature to a pre-determined target selected by the physician.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 106 kg/235 lbs
• 43.2cm/17 in
• Height: With monitor: 131 cm/51.5 in ; Height: Without monitor: 100 cm/39.5 in
• 44.5 cm/17.5 in
• 0-2400 mL/min ±15%

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

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

• Z1204021501MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT