Omnifix® F Luer Solo 1 ml Fine Dosage Syringe (Box of 100)
Omnifix
Single-use sterile hypodermic syringe (medical device)3-piece 1 ml fine dosage syringe with Luer connector, without needle
Certifications
- Manufactured according to ISO 7886 1 for sterile hypodermic syringes for single use.
- CE Marked medical device (as evidenced by B. Braun documentation and available Declarations of Conformity for Omnifix® F Luer Solo).
- Not manufactured with PVC, BPA, DEHP or natural latex, supporting compliance with internal material policies and some environmental and occupational health preferences.
- Produced by B. Braun Melsungen AG, an established medical device manufacturer operating certified quality management systems for medical devices (e.g. ISO 13485) across its syringe and needle product lines.
- Supplied sterile and designated as a single Use device, meeting regulatory requirements for sterile barrier integrity and labelling for single Use hypodermic syringes.
- Manufactured according to ISO 7886 1 for sterile hypodermic syringes for single use.
- CE Marked medical device (as evidenced by B. Braun documentation and available Declarations of Conformity for Omnifix® F Luer Solo).
- Not manufactured with PVC, BPA, DEHP or natural latex, supporting compliance with internal material policies and some environmental and occupational health preferences.
- Produced by B. Braun Melsungen AG, an established medical device manufacturer operating certified quality management systems for medical devices (e.g. ISO 13485) across its syringe and needle product lines.
- Supplied sterile and designated as a single Use device, meeting regulatory requirements for sterile barrier integrity and labelling for single Use hypodermic syringes.
3-piece 1 ml fine dosage syringe with Luer connector, without needle
Description
Omnifix®-F Luer Solo 1 ml Fine Dosage Syringes are single-use, 3-piece hypodermic syringes with a centric Luer connector and no attached needle, designed for precise administration, aspiration and preparation of very small fluid volumes. Each syringe features a highly transparent polypropylene barrel with fine 0.01 ml graduation and high-contrast black scale for exact dosing, a polystyrene plunger, and a polyisoprene plunger stopper with a double sealing ring that enables controlled, slow aspiration and injection while minimising residual volume. The syringes are not manufactured with PVC, BPA, DEHP or natural latex and are individually sterile-packed. They are intended for aspiration and injection of fluids via multiple clinical access routes, admixture of medicines into infusion solutions, and extraction of body fluids and tissue in adults, paediatric patients and neonates. The Medisave listing supplies these syringes as a box of 100 for use in injection, infusion, nutrition and other clinical or laboratory applications.
Bnefits
- Fine 0.01 ml graduation on the 1 ml barrel enables highly precise dosing of very small volumes.
- Highly transparent barrel with high-contrast black printing allows easy reading of the scale and accurate dose verification.
- 3-piece design with polyisoprene plunger stopper and double sealing ring supports smooth, slow aspiration and injection and helps minimise leakage and residual volume.
- Safe plunger backstop helps prevent accidental plunger withdrawal and loss of fluid from the syringe.
- Made without polyvinylchloride (PVC), bisphenol A (BPA), diethylhexylphthalate (DEHP) and natural latex, reducing the risk of material-related sensitivities and simplifying waste handling.
- Individually sterile-packed, single-use syringes intended to support infection prevention and safe clinical practice.
- Versatile indications: suitable for aspiration and injection via intravascular, intramuscular, subcutaneous, intracutaneous, intrathecal, intranasal, enteral, intraurethral, intravaginal, joint and soft-tissue routes when used with compatible devices.
- Designed and manufactured according to ISO 7886-1, providing conformity with international standards for sterile hypodermic syringes.
- No age or gender limitations; can be used in adults, paediatrics and neonates when clinically appropriate.
Indications
- Aspiration and injection of fluids in combination with adequate medical devices via clinically intended access routes including intravascular, intramuscular, subcutaneous, intracutaneous, intrathecal, intranasal, enteral, intraurethral, intravaginal, and joint and soft tissue injections.
- Admixture of drugs to an infusion solution, in combination with appropriate infusion equipment and in accordance with the summary of product characteristics (SmPC) of the medication.
- Extraction of body fluids and tissue via aspiration when used together with appropriate medical devices (e.g. cannulae, needles).
- General use in infusion therapy, injection therapy, nutrition therapy and extraction of body fluids and tissue, wherever a 3-piece fine dosage syringe is prescribed.
- Use in adult, paediatric and neonatal patients; the manufacturer states that there are no age- or gender-related limitations for the syringe itself (clinical suitability depends on the therapy and device combination).
Composition
- Barrel material: Polypropylene.
- Plunger material: Polystyrene (polystyrol).
- Plunger stopper material: Polyisoprene (synthetic, natural-latex-free) with double sealing ring.
- Printing: High-contrast black graduation markings on the barrel.
- The syringes are specified as not manufactured with polyvinylchloride (PVC), bisphenol A (BPA), diethylhexylphthalate (DEHP) or natural latex.
- Sterilisation method is not explicitly detailed in public summaries but the syringes are supplied sterile and individually packed as single-use medical devices.
Formulation
- Device type: Single-use, sterile 3-piece fine dosage hypodermic syringe with centric Luer connector and no attached needle.
- Nominal volume: 1 ml with 0.01 ml graduation intervals for fine dosing.
- Design: Transparent barrel with permanent scale, polystyrene plunger and polyisoprene plunger stopper incorporating a double sealing ring, providing smooth movement and tight sealing.
- Connector: Luer cone (centric) compatible with standard Luer devices (needles, infusion lines, connectors) according to ISO 7886-1.
- Dead space: Low residual volume due to plunger and barrel design, supporting efficient use of small-volume medicines and solutions.
- Packaging format: Individually sterile blister-packed syringes supplied in a dispenser box of 100 units.
Packaging
- Primary packaging: Each syringe is individually packed in a sterile blister or peel-open pack, designed for single use.
- Secondary packaging: Dispenser box containing 100 individually packed Omnifix®-F Luer Solo 1 ml syringes (as per Medisave listing for the box of 100).
- Labelling includes product name (Omnifix®-F Luer Solo), nominal volume (1 ml), fine dosage graduation (0.01 ml), Luer connector, single-use symbol, sterile symbol and manufacturer details (B. Braun).
- Higher-level shipping packaging: multiple dispenser boxes may be packed in outer cartons for distribution; details depend on the logistics configuration and are not fully specified in public product summaries.
Usage
- Intended for single use only; do not reuse, reprocess or resterilise the syringe.
- Before use, check that the sterile packaging is intact and that the product is within its expiry date; do not use if packaging is damaged or compromised.
- Attach an appropriate sterile needle or compatible Luer device to the Luer connector, ensuring a secure fit.
- For aspiration and injection of fluids: draw back the plunger slowly to aspirate the required volume, using the 0.01 ml graduation scale to adjust the dose precisely; then inject at the prescribed rate using appropriate clinical technique for the chosen route (e.g. intravascular, intramuscular, subcutaneous).
- For admixture of drugs to an infusion solution: use the syringe with appropriate access devices (e.g. vial adaptors, injection ports) and follow the SPC of the medication and local protocols for reconstitution and admixture.
- For extraction of body fluids and tissue: connect to suitable cannulae or devices, aspirate the required material and handle the sample according to institutional guidelines.
- Operate the plunger smoothly to take advantage of the plunger stopper’s double sealing ring which allows controlled, slow aspiration and injection while reducing the risk of sudden plunger movement.
- Use care to avoid inadvertent plunger withdrawal beyond the safe plunger backstop; the integrated backstop is designed to help prevent accidental removal of the plunger and loss of contents.
- Dispose of used syringes immediately after use in an approved sharps or clinical waste container, in accordance with local infection prevention and waste management policies.
Contraindications
- No specific patient-related contraindications are listed for the syringe itself in manufacturer summaries; use is governed by the contraindications of the medicines or therapies being administered.
- The syringe should not be used if the sterile packaging is damaged or opened prior to use.
- Do not use in cases where material incompatibility with polypropylene, polystyrene or polyisoprene is known or suspected in the clinical set-up; compatibility of all connected devices and substances should be ensured by the user.
- Do not reuse or resterilise; reuse can lead to contamination, infection risk and mechanical failure.
Adverse Effects
- No direct adverse effects are attributed to the syringe itself in public manufacturer documentation; adverse events are primarily associated with the injected agents or procedural complications.
- Potential risks associated with misuse or improper handling include contamination and infection, incorrect dosing due to misreading of the scale, leakage or loss of fluid if the Luer connection is not secure, and needlestick or sharps injuries when used with needles.
- As with any injection device, inappropriate technique or use with unsuitable medicines or access routes may contribute to local tissue injury, extravasation or other procedure-related complications.
Storage Conditions
- Store in a clean, dry environment in the original packaging until use.
- Protect from excessive heat, moisture and direct sunlight; do not expose to conditions that could compromise the sterile barrier or deform plastic components.
- Do not use after the expiry date printed on the packaging.
- Keep out of the reach of children.
- Avoid mechanical damage (crushing, bending or puncturing) of the boxed syringes during transport and storage.
Duration
Not publicly listed (as a reusable-therapy-independent device, the syringe has no inherent treatment duration; duration is determined entirely by the clinical procedure and therapy in which it is used).
Onset
Not publicly listed (as a medical device for fluid aspiration and injection, the syringe itself has no pharmacological onset of effect; onset depends on the medication or intervention delivered).
