URINARY CATHETER, nelaton, sterile, s.u., CH 10, 40 cm

STD SCTDCAUN10-

Valid Article

Former Code(s): -X
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.
U01010502 - Nelaton catheters, non self-lubricating
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.
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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URINARY CATHETER, NELATON

Definition

Flexible tubular device which is inserted into the bladder through the urethra to drain away urine intermittently (= intermittent urinary catheterization).

Synonym

Nelaton catheter

Specifications

Quality standards

ISO 20696, 2018, edition 1, (confirmed 2023) Sterile urethral catheters for single use

Technical specifications

  • Transparent PVC
  • One-way catheter
  • Without balloon
  • Straight distal end with side eyes
  • ​Size: CH 10
  • Length of the catheter:
    • SCTDCAUN10S: 10 - 25 cm
    • SCTDCAUN10-: +/- 40 cm
  • Proximal end with funnel shape connector, colour coded for the size (CH 10 = black)
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

Please consult the “Manual of nursing Care Procedures, MSF, 2020” available online via the Nursing care working Group sharepoint page.

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Precautions for Use

Not suitable for indwelling urinary catheterization which requires a Foley catheter with balloon (see related articles below).

Storage

  • Store below 30°C
  • Protect from sunlight ‐ Protect from humidity
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