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FILTER for IV LINE, 0.2 µm, neonatal

https://unicat.msf.org/cat/product/56514
STD SINSIVFI2N-

Valid Article

Former Code(s): SINSZBE0085 SINSINFI2N-
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).
Article is intended to be used with children (<12 years) ONLY.
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.
A04010101 - Withdrawal and administration filters (0.2-1.2 microns)
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PE
The order of this product needs to be justified and is only acceptable under certain conditions.
CT3+
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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FILTER for IV LINE, 0.2 µm

Definition

A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device.

Specifications

Air eliminating filters are used in infusion sets for the dual purpose of filtering particulates and eliminating bubbles. Filters are comprised of housing with a vented side, separated from the patient side by a 0.2 micron filter membrane. Fluid enters the upstream inlet and fills the vented side first, then passes through the filter to the patient side. Air can pass out through the vents, but once the filter membrane is wet, it will not allow air to pass through to the patient side.

Quality standards

ISO 8536-11, 2015, edition 2, (confirmed 2021) Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment

Technical specifications

  • Polycarbonate housing
  • Non charged filter membrane made of Polyethersulfone (PES) with 0.2 µm pores (written on the housing)
  • Low protein binding
  • Two 0.02 μm hydrophobic PTFE-membranes for venting
  • Connections at both sides of the filter with male Luer lock fittings
  • Some have short extension sets connected: the adult and neonatal one of B.Braun (but not the child one)
  • The flow direction of the fluid is indicated with an arrow on the housing
  • Sterile, for single use

Instructions for use

Proper technique for priming the in-line filter

  • Close roller clamp.
  • Spike solution container and hang.
  • Squeeze and release middle of drip chamber until approximately 2 /3 full. Open vent cap on spike after filling drip chamber if container requires venting.
  • Open roller clamp to prime. DO NOT INVERT FILTER. Close roller clamp.
  • If there is a clamp below the filter, close it after priming.
  • Attach the set to the patient's IV access port, then open clamp(s).

Precautions for Use

Use of filters should adhere to the manufacturer's guidelines and the filtration requirements of the therapy

MSF requirements

It is recommended using them (in children and adults) for mannitol, phenytoin (if diluted), and amiodarone

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