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PENIS SHEATH, latex, self-adhesive + collar, Ø31-35mm

https://unicat.msf.org/cat/product/65436
STD SCTDUIPS3135

Valid Article

Former Code(s): SMSUZBD0018 SMSUUIPS3135
Single patient multiple 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.
U070201 - Sheath catheter for the treatment of incontinence
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
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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INCONTINENCE SHEATH, latex

Definition

A non-sterile, urine drainage device for men that consists of a flexible tube attached to a condom-like sheath. The sheath is fitted over the penis to channel urine, via the tube, into a collection bag. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention

Synonym

Urinary Condom Catheter, male external catheter

Specifications

    Must be used with urine collector bags

    Technical specifications

    Flexible sheath that fits over the penis just like a condom:

    • Large auto-adhesive band witch allows the maintains of the incontinence sheath once in place
    • Applicator collar to facilitate the installation
    • Material : latex, ​phtalate free
    • Selected sizes:
      • Ø 22-25 mm
      • Ø 26-30 mm
      • Ø 31-35 mm
    • Non sterile

    Packaging & Labelling

    Unit packaging

    Instructions for use

    A condom catheter is an option as a bladder containment strategy for men who have problems with urinary incontinence. They are most often used in patients with neurologic disorders.

    Nursing challenges

    • proper fit and application of the catheter, which depends on use of the correct-sized catheter, and the application technique
    • maintenance of skin integrity and cleanliness of the penis
    • ensuring free flow of urine to prevent backflow and possible displacement of the condom catheter
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