TSP1019.0

Organization name

ThermaSolutions Europe BV

SRN

NL-MF-000022782

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  Do not use if the sterile pouch is damaged
• CW032

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 12 countries total.

Trade name

not provided

UDI-DI code

00851450007169

Basic UDI-DI

B-00851450007169

Reference / catalog number

TSP1019.0

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Hyperthermic Perfusion Kit is a sterile single use procedure kit. The disposable is compatible with both the ThermoChem™ HT-2000 and HT-2500 devices.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Gross Weight 4,5 Kg; Net Weight 4,3 Kg

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

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

• Z12040219REGIONAL PERFUSION UNITS