SM000010B

Trade name

not provided

03700512915607

037005129INF-ESTT

Reference / catalog number

SM000010B

GS1

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The Infusion lines cover single use devices, designed for a use from limited use to short-term use. Promepla Infusion lines are intended for use in the administration of intravenous or subcutaneous fluids or as accessories, especially to be used during hemodialysis procedures (performed with hemodialysis central venous catheter access). The Infusion lines family are divided into three categories. The medical devices intended for the intravenous administration are intended to be connected on one side to peripheral intravenous cannulas or needles which are inserted into a vein and a pressure infusion machine on the other side for most cases or syringes/fluids bags. The medical devices intended for the subcutaneous administration are intended to be connected on one side to peripheral subcutaneous invasive device and a pressure infusion machine on the other side for most cases or syringes/fluids bags. The lines can also be completed by a clamp to activate or interrupt fluid circulation. The medical device intended to be an accessory are intended to ensure connection between the hemodialysis central venous catheter (CVC) of a patient and the bloodlines or other extension lines connected to a hemodialyzer or a needleless syringe.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• A03040199INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER