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LUBRICANT, water based, sterile, unidose, 5g

https://unicat.msf.org/cat/product/66424
STD SMSULUBRW05S

Valid Article

Former Code(s): SMSULUBRW05-
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.
V9007 - Sterile instrument lubricants
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
CT30
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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LUBRICANT, water based, sterile, unidose,

Definition

A sterile substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; or to be applied to a sterile surgical instrument prior to use for device mechanical and patient lubrication purposes (e.g., to facilitate moving parts of device, and to facilitate movement between instrument and patient).

Specifications

  • Water-based lubricant: water-soluble cellulose ether or glycerin solution
  • No antimicrobial agents added
  • Translucid, odourless, neutral pH (between 6.6 and 7.6)
  • Compatible with mucosa
  • Compatible with the latex of condoms and gloves
  • Non-staining
  • Forms a translucent film that adheres well, yet washes away easily
  • Unidose: 5 g package: foilpack / sachet / tube with snap-off tip (can be metal or laminated)
  • Sterile, for single use

Instructions for use

Can be used for all medical procedures (insertion of urinary catheter, vaginal examination, insertion of tracheostomy tube,..)

Precautions for Use

Do not use oil-based lubricant gel: they increase the likelihood of breakage and slipping of latex gloves due to loss of elasticity caused by these lubricants. Oil may also create tiny holes in the latex.

Storage

Store below 30°C - Protect from sunlight

MSF requirements

For insertion of urinary catheters

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