INTRAVENOUS CATHETER HOLDER, sterile, s.u., universal

STD SINSIVCH1--

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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INTRAVENOUS CATHETER HOLDER, universal

Definition

A sterile device designed to fix an intravenous catheter, catheter needle, or a tube attached to an intravenous catheter on a patient's body without suturing. It is designed as an adhesive pad that attaches to the patient's skin. The exposed side has an integrated fixation mechanism to hold the catheter in place at its hub or tubing. It is used with a central venous catheter (CVC) or a peripherally inserted central catheter (PICC).

Specifications

Technical specifications

  • adhesive pad that attaches to the patient's skin
  • hypoallergenic latex free skin contact adhesive
  • integrated fixation mechanism on the exposed side to hold the catheter in place at its hub or tubing
  • sterile, for single use

Some models have a foam cut-out that matches the shape of the PICC or CVC catheter hub for proper positioning and additional horizontal securement (catheter brand specific), other models are more universal and secure tubes and a variety of hub sizes and shapes.

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

Follow manufacturer's recommendation for application and removal.

Some (Statlock®devices) have to be loosened with alcohol.

Precautions for Use

  • Remove oil and moisturizer from targeted skin area.
  • Monitor the stabilization device daily and replace when clinically needed, at least every 7 days and with every dressing change.
  • Always secure the central venous and PICC catheters by applying an adhesive strip near the insertion site before installing or using a stabilization device.

MSF requirements

It is used with a central venous catheter (CVC) or a peripherally inserted central catheter (PICC), avoids the use of stitches to maintain the catheter in place.

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