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URINE FLOWMETER, grad. 400ml overflow 2l drain. bag, ster.

https://unicat.msf.org/cat/product/76870
STD SCTDBAGUF42

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.
A06030302 - Urine flowmeter sets
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.
I sterile
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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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URINE FLOWMETER

Definition

A sterile device that is used to measure precisely the urine output of a catheterized patient. The device includes a graduated drip chamber which can be emptied into a drainable 2L bag with an overflow system. It is used for patients requiring close monitoring of urine output on an hourly basis.

Specifications

Quality standards

ISO 8669-2, 1996, edition 2, (confirmed 2017) Urine collection bags - Part 2: Requirements and test methods

Technical specifications

  • Precision urimeter
    • rigid container
    • capacity 400 ml
    • graduations: 1 ml for the first 45 ml, per 5 ml for the remaining 400 ml
    • no-return system
    • automatic overflow towards the urine bag
  • Bag:
    • flexible plastic, transparent frontside
    • capacity: 2 litres
    • graduations every 50 ml up to 500 ml, then per 100 ml up to 2l
    • non-return valve at the tube inlet
    • emptying system, single handed manipulation
    • integrated hanging hook
  • Drainage tube:
    • flexible plastic
    • length: ± 150 cm
    • diameter: 8 mm
    • universal connector for connecting to a catheter
    • needle-free sampling port to be used with a Luer syringe
    • protective cap
  • Inside AND outside sterile device, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

MSF requirements

Hourly urine output is largely admitted to be an important monitoring parameter in severely ill patients in many settings including: OTs, ICUs, Emergency departments PICU/NICU, burn units.

Hourly urine output values are often recommended as a target for IV fluid and vasopressor therapy in states of shock.

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