STFE1602SD-B

Organization name

STERIFAST - STERILIZATION & DISINFECTION SYSTEMS LDA.

SRN

PT-MF-000012426

Manufacturer status

Active

Primary placement in Poland; available across 2 countries total.

Trade name

not provided

UDI-DI code

05600778703094

Basic UDI-DI

B-05600778703094

Reference / catalog number

STFE1602SD-B

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

It is a low temperature sterilizer that uses an aqueous solution of hydrogen peroxide in low concentration (35%) as the sterilizing agent, specifically intended to sterilize medical devices in general as well as temperature sensitive medical devices in a medical environment, according to instructions provided in the Instruction Manual. The intended users are specifically health-care professionals. The items to sterilize are placed in the sterilization chamber that is heated at a predefined temperature. Then, the chamber is submitted to a deep vacuum. After, the sterilizing agent is injected into a vaporizer that vaporizes it to the sterilization chamber. The control of the quantity of sterilizing agent is done by the number of pulses of the vaporizer entry valve. After a specific time of exposure to the sterilizing agent, the exhaust opens and the plasma generator is activated until a determined vacuum is reached. Then, a quantity of air is injected in the chamber controlled by pressure. After this phase, the chamber is submitted to several ventilations by entries of air and withdraws by vacuum. After this phase the aeration valve opens and the control systems waits until atmospheric pressure is reached. The cycle ends and the systems prints out a report with the several cycle phases, times, temperature and pressure. The sterilizer has 3 sterilization cycles and 3 test cycles.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• S900199DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER