Omnifix® Luer Lock Syringe 5 Range

Omnifix® Luer Lock Syringe 5 Range

Omnifix

Single-use sterile hypodermic syringe (medical device)
  • Manufactured in accordance with ISO 7886 1 for sterile hypodermic syringes for single use.
  • Luer Lock syringes in the 2–50 ml Omnifix range are also manufactured in accordance with ISO 7886 2 (syringes used with power Driven syringe pumps).
  • CE Marked medical device (as a sterile hypodermic syringe) under applicable European medical device regulations.
  • Natural Latex Free construction, as stated in product data sheets for Omnifix Solo syringes.
  • Material biocompatibility supported by compliance of polypropylene and polyisoprene components with relevant medical device standards (e.g. ISO 10993, referenced in broader Omnifix documentation).
  • Released by B. Braun for use with certain Perfusor syringe pumps (2–50 ml Luer Lock syringes) in controlled infusion applications, indicating pump compatibility validation.
3-piece 5 ml syringe with centric Luer Lock connector, without needle

Description

Omnifix® Luer Lock Solo 5 ml syringes are single-use, sterile, 3-piece hypodermic syringes with a centric Luer Lock connector and no attached needle. Designed by B. Braun for aspiration and injection of fluids, admixture of medicines and extraction of body fluids, they feature a highly transparent polypropylene barrel with clear black graduation, a polypropylene plunger and a polyisoprene plunger stopper with a double sealing ring. The syringes are suitable for a wide range of clinical applications, including intravascular, intramuscular, subcutaneous, intracutaneous, intrathecal, intranasal, enteral, intraurethral, intravaginal, joint and soft tissue injections when used with appropriate medical devices. Omnifix Luer Lock Solo syringes are supplied latex free, not manufactured with PVC, BPA or DEHP, and are manufactured in accordance with ISO 7886-1 and ISO 7886-2. The Medisave product listing supplies these syringes as a pack of 100 for use in injection, infusion and nutrition therapies and in combination with compatible B. Braun Perfusor syringe pumps (for sizes 2–50 ml).

Bnefits

  • 3-piece syringe design with separate plunger stopper for smooth, controlled plunger movement and reliable sealing.
  • Centric Luer Lock connector enables secure connection to needles, infusion lines and other compatible Luer Lock medical devices.
  • Highly transparent barrel with high-contrast black graduation for easy reading and precise dose setting.
  • Fine 5 ml scale with clear graduation allows accurate measurement of small to moderate volumes.
  • Plunger stopper with double sealing ring supports slow, controlled aspiration and injection and helps prevent back leakage.
  • Safe plunger backstop helps prevent accidental plunger withdrawal and loss of fluid from the syringe.
  • Released for use with B. Braun Perfusor Space, Spaceplus Perfusor and Perfusor compactplus syringe pumps (2–50 ml Luer Lock syringes), enabling use in infusion and syringe-pump therapies.
  • Not manufactured with polyvinylchloride (PVC), bisphenol A (BPA), diethylhexylphthalate (DEHP) or natural latex, reducing material-related sensitivities.
  • Manufactured according to ISO 7886-1 (and ISO 7886-2 for 2–50 ml Luer Lock syringes), ensuring compliance with international standards for sterile hypodermic syringes.
  • No age or gender limitations; suitable for adults, paediatric patients and neonates when used as part of appropriate clinical therapy.

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 into an infusion solution according to the summary of product characteristics (SmPC) of the medication, in combination with appropriate infusion systems and access devices.
  • Extraction of body fluids and tissue via aspiration when used with suitable medical devices (such as needles, catheters or cannulae).
  • Use in infusion therapy, injection therapy, nutrition therapy, and procedures requiring withdrawal or injection of precise fluid volumes.
  • Suitable for use in combination with compatible B. Braun Perfusor syringe pumps (2–50 ml sizes) for infusion and syringe-pump based therapies.
  • Device itself has no age or gender restrictions and can be used in adults, paediatrics and neonates, subject to clinical judgement and therapy requirements.

Composition

  • Barrel material: Polypropylene.
  • Plunger rod material: Polypropylene.
  • Plunger stopper material: Polyisoprene (synthetic, natural-latex-free).
  • Lubricant: Silicone oil mixture (used on the plunger/stopper for smooth movement), as listed in independent composition comparisons for B. Braun Omnifix Luer Lock Solo syringes.
  • Sterilisation method: Ethylene oxide, reported for B. Braun Omnifix Luer Lock Solo syringes in composition comparison documents.
  • Not manufactured with Polyvinylchloride (PVC).
  • Not manufactured with Bisphenol A (BPA).
  • Not manufactured with Diethylhexylphthalate (DEHP).
  • Not manufactured with natural latex.

Formulation

  • Device type: Single-use, sterile, 3-piece hypodermic syringe without needle.
  • Nominal volume: 5 ml.
  • Connector type: Centric Luer Lock connector for secure attachment to compatible Luer Lock needles and devices.
  • Graduation: High-contrast black graduation printed on a transparent barrel for easy visual verification of the dose.
  • Mechanical features: Plunger stopper with double sealing ring for controlled aspiration/injection and reduced leakage; safe plunger backstop to prevent accidental plunger removal.
  • Material combination: Polypropylene barrel and plunger with polyisoprene stopper, providing chemical resistance and mechanical stability for typical injectable medicines and solutions.
  • Sterility: Supplied sterile for single use; intended to remain sterile until the primary pack is opened.
  • Compatibility: 2–50 ml Omnifix Luer Lock Solo syringes are released for use with B. Braun Perfusor Space, Spaceplus Perfusor and Perfusor compactplus syringe pumps.

Packaging

  • Primary packaging: Each syringe is individually packed in a sterile blister or peel-open pack.
  • Secondary packaging: Pack of 100 individually sterile-packed Omnifix Luer Lock Solo 5 ml syringes, as specified by Medisave and other distributors.
  • Outer packaging and labelling: Carton indicating product name (Omnifix Luer Lock Solo), volume (5 ml), quantity (100), single-use symbol, sterile status, Lot number, expiry date, and manufacturer (B. Braun Melsungen AG).
  • Department packaging: B. Braun product data sheets describe Omnifix Solo syringes as supplied in department packs of 100 units.

Usage

  • Intended for single use only; do not reuse, reprocess or resterilise the syringe.
  • Before use, inspect the sterile pack; do not use if the packaging is damaged or opened, or if the expiry date has passed.
  • Attach a suitable sterile Luer Lock needle or compatible medical device (e.g. infusion tubing, connector) securely to the centric Luer Lock cone.
  • For aspiration and injection of fluids: pull back the plunger slowly to aspirate the required volume, using the graduation marks for accurate dosing, then inject at the prescribed rate using appropriate technique for the intended route.
  • For admixture of medicines into infusion bags or bottles: use with appropriate access devices (e.g. vial adaptors, injection ports) and follow the SmPC of the medicinal product and local protocols for preparation and admixture.
  • For extraction of body fluids and tissue: connect to the appropriate access device (needle, cannula, catheter) and aspirate as required, observing local infection prevention and biosafety procedures.
  • Use smooth, controlled plunger movement to take advantage of the double sealing ring design, allowing slow aspiration and injection while reducing sudden changes in pressure.
  • After use, immediately dispose of the syringe (and needle, if attached) in an approved sharps or clinical waste container, according to local regulations and institutional policies.

Contraindications

  • No specific patient-related contraindications are listed for the syringe itself in manufacturer summaries; its use is governed by the contraindications of the medicines or therapies being administered.
  • Do not use if the sterile packaging is damaged, opened or compromised before use.
  • Do not reuse; reuse of single-use syringes may result in infection, contamination, loss of performance and device failure.
  • Do not use in situations where incompatibility with polypropylene, polyisoprene or silicone oil is known or suspected within the fluid path or connected devices.
  • Avoid use if there are local or institutional restrictions on specific syringe types or materials for certain therapies (e.g. highly specialised applications).

Adverse Effects

  • No direct adverse effects are attributed to the syringe itself in B. Braun product information; adverse events typically relate to the injected substances or the clinical procedure.
  • Potential risks from improper use include contamination and subsequent infection, incorrect dosing due to misreading of the scale, leakage or disconnection if the Luer Lock is not properly secured, and needlestick or sharps injuries when used with needles.
  • As with any injection device, inadequate technique or inappropriate route of administration can contribute to local tissue damage, extravasation or other procedure-related complications.

Storage Conditions

  • Store in a clean, dry environment in the original packaging until use.
  • Protect from extreme temperatures, moisture and direct sunlight; avoid conditions that could deform plastic components or compromise packaging integrity.
  • Do not use after the expiry date printed on the packaging.
  • Avoid mechanical damage (crushing, bending or puncturing) of the syringe packs during storage and transport.
  • Keep out of the reach of children.
  • Do not attempt to resterilise or reuse syringes; dispose of expired or damaged stock according to local medical device and clinical waste regulations.

Duration

Not publicly listed (as a non-medicinal injection device, the syringe is used only for the duration of the clinical procedure; treatment duration is determined by the therapy and medication, not by the syringe itself).

Onset

Not publicly listed (the syringe has no pharmacological effect; onset and duration of action are determined by the medicines or fluids administered).

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