PDT-5500

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

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 18 countries total.

Trade name

not provided

UDI-DI code

00851450007213

Basic UDI-DI

B-00851450007213

Reference / catalog number

PDT-5500

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

Single-use stainless steel nebulizer with high pressure tubing to administer liquid medications during laparoscopy / minimally invasive surgery. Suitable for PIPAC therapy.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 1-15µm, average droplet size 3.16µm
• 68.5 MU24
• 8 MU50
• 206 MU50

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

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

• Z12159002AEROSOL EQUIPMENT