1 box of 15 sterile 0.9% sodium chloride solutions of 500ml - physiological saline - Omnia - Delynov (32.E0001.00)
The 1 carton de 15 Solutions stérile de chlorure de sodium à 0,9% de 500 ml - serum physiologique - Omnia is a medical device manufactured by Omnia S.p.A. — Class I, CE marking CE14590.
- Compliance: Medical device Class I, CE marking CE14590.
- Manufacturer: Omnia S.p.A..
- Reference: 32.E0001.00.
- Reserved for healthcare professionals. Read instructions carefully before use.
fabricant :OMNIA S.R.L. IT - 43036 FIDENZA (PR) - VIA FRANCESCO DELNEVO 190 réservé aux professionnels de santé.Lire attentivement la notice avant utilisation.
What is the Omnia 0.9% sodium chloride sterile solution?
The 0.9% sodium chloride sterile solution from the Omnia brand is an isotonic preparation, commonly known as physiological saline or NaCl. This product is specifically packaged in 500 ml bottles, delivered in boxes of 15 units to meet the logistical needs of surgical practices. This sterile solution is an essential item in clinical environments for various rinsing and cleaning applications. It guarantees purity in compliance with medical requirements for maintaining asepsis during invasive procedures. The manufacturer Omnia S.p.A. ensures rigorous manufacturing quality for this Class I medical device, which is essential for the daily practice of healthcare professionals.
What are the clinical indications for this physiological saline?
This physiological saline is indicated for healthcare professionals practicing oral surgery, implantology, or periodontology. Its primary use involves the irrigation of operative sites, cleaning of soft tissues, and rinsing of medical devices during interventions. The 0.9% sodium chloride solution maintains the hydration of exposed tissues without causing osmotic shock, thanks to its isotonicity. It is also used for cooling rotary instruments during implant placement, thus preventing thermal necrosis of the bone. The use of this Omnia sterile solution is strictly reserved for qualified healthcare professionals.
What are the technical characteristics of reference 32.E0001.00?
Technical reference 32.E0001.00 corresponds to a box of 15 sodium chloride 0.9% solutions with a unit volume of 500 ml. Each bottle contains a sterile NaCl solution, formulated to be isotonic with body fluids. This packaging in boxes of 15 units is optimized for stock management in operating rooms or dental offices. The product is designed by Omnia S.p.A. to guarantee perfect sterility until opening. It is important to note that this solution is non-injectable. The transparency of the bottle allows for quick visual inspection of the solution's integrity before any clinical use.
What are the contraindications for the use of this sodium solution?
In accordance with the warnings from the manufacturer OMNIA S.R.L., the use of this sterile sodium chloride solution is strictly reserved for healthcare professionals. Although specific contraindications are not detailed beyond the intended use, it is imperative not to use the product if the packaging or bottle shows signs of damage, compromising sterility. This solution is non-injectable and must therefore not be administered intravenously. It is recommended to read the instructions carefully before any use to ensure compatibility with the planned procedures and to comply with current hygiene protocols.
What are the precautions for use for this medical device?
The use of Omnia sterile sodium chloride solution requires rigorous compliance with aseptic rules. Once the 500 ml bottle is opened, the solution must be used immediately to guarantee its sterility. Any remaining unused product after the intervention must be systematically discarded, as the solution contains no preservatives. Professionals must ensure that the cap and bottle have not been tampered with before use. As with any Class I medical device used in surgery, storage must be in a clean, dry place, away from direct light, to preserve the physicochemical properties of the 0.9% NaCl.
Who is the manufacturer and what standards are respected?
The device is manufactured by Omnia S.p.A. (OMNIA S.R.L.), located in Fidenza, Italy. This product bears the CE14590 marking, certifying its compliance with European safety and performance requirements. It is classified as a Class I medical device according to the current regulation (MDR). Manufacturing by Omnia S.p.A. guarantees full traceability and compliance with sterilization standards for sodium chloride solutions. Healthcare professionals can refer to the manufacturer's contact details in Fidenza for any additional technical information, while ensuring they scrupulously follow the indications and warnings provided in the official instructions.
State of the art
Single-use sterile surgical kits significantly reduce intraoperative contamination.
Specifications
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