Engineered for high-precision volumetric intravenous dosing. Fully compliant with ISO 8536-5, featuring automatic shut-off floating valves, DEHP-free medical-grade polymers, and micro-drip calibration for pediatric, neonatal, and ICU applications.
Integrated micro-droplet pins and crystal-clear 100ml/150ml chambers designed to satisfy strict Ministry of Health tender requirements worldwide.
Addressing the critical clinical, material, and regulatory queries evaluated by healthcare procurement boards, biomedical engineers, and pharmaceutical importers.
A Measured Volume Burette Set (frequently referred to in clinical tenders as a Burette Infusion Set, Pedipack Set, or Microdrip Volumetric Administration Set) is a specialized IV delivery system engineered for the precise, controlled administration of critical intravenous fluids and potent pharmaceuticals. Unlike standard gravity IV sets, a burette set incorporates a rigid, graduated 100 ml or 150 ml cylindrical chamber, a calibrated micro-drip orifice delivering exactly 60 drops per milliliter (60 drops = 1 ml ± 0.1 ml), an internal 15-micron fluid filter, and an automatic floating shut-off valve designed to arrest fluid flow automatically once the measured dose empties. This mechanical air-blocking safety feature prevents air embolism in fragile pediatric, neonatal, and geriatric patients.
In modern clinical settings, particularly within Intensive Care Units (ICU), Pediatric Intensive Care Units (PICU), and Neonatal Intensive Care Units (NICU), accuracy in intravenous fluid delivery is a matter of life-saving necessity. A minor dosage discrepancy that might be negligible in an adult patient can precipitate severe fluid overload, metabolic imbalance, or toxic therapeutic exposure in a low-birth-weight infant. Mediplus India (Shree Umiya Surgical Pvt. Ltd.) manufactures high-precision Measured Volume Burette Sets engineered specifically to eliminate volumetric variance, prevent catheter occlusion, and deliver guaranteed sterility across global healthcare distribution networks.
Manufactured from non-toxic, bio-compatible medical polymers under stringent cleanroom environment parameters.
Features a 100 ml rigid, transparent, scale-calibrated chamber. Ideal for neonatal and pediatric precise micro-dosing. Fitted with an auto shut-off floating disc, bacterial air vent, and needle-free or injection site Y-connector.
Designed for pediatric and adult critical care requiring higher volumetric capacity. Clear micro-graduations at 1 ml intervals, flexible drip chamber with 60 drops/ml dropper, and soft kink-resistant medical tubing.
Specialized oncology and parenteral nutrition infusion sets. Constructed with TOTM-plasticized non-DEHP tubing and UV-blocking amber chambers preventing drug degradation up to 450nm.
To assist healthcare procurement specialists and biomedical evaluation committees in submitting exact specifications for international tenders, the table below outlines the structural and performance parameters of our Measured Volume Burette Set product portfolio:
| Technical Parameter | 100 ml Standard Specification | 150 ml Extended Specification | Oncology / UV-Light Protected Specification |
|---|---|---|---|
| Burette Chamber Capacity | 100 ml (Graduated 0–100 ml at 1 ml intervals) | 150 ml (Graduated 0–150 ml at 1 ml intervals) | 100 ml / 150 ml Amber Tinted Chamber |
| Drop Factor Calibration | Microdrip: 60 Drops = 1.0 ml ± 0.1 ml | Microdrip: 60 Drops = 1.0 ml ± 0.1 ml | Microdrip: 60 Drops = 1.0 ml ± 0.1 ml |
| Safety Shut-Off Mechanism | Hydrophobic Automatic Floating Shut-off Valve | Hydrophobic Automatic Floating Shut-off Valve | Hydrophobic Automatic Floating Shut-off Valve |
| Air Venting Filtration | 0.22 µm Hydrophobic Bacterial Air Filter | 0.22 µm Hydrophobic Bacterial Air Filter | 0.22 µm Hydrophobic Bacterial Air Filter |
| Fluid Path Filter | 15 µm Fluid Filter inside Drip Chamber | 15 µm Fluid Filter inside Drip Chamber | 15 µm Fluid Filter inside Drip Chamber |
| Material Composition | Medical Grade Non-Toxic PVC (DEHP-Free Optional) | Medical Grade Non-Toxic PVC (DEHP-Free Optional) | TOTM / DINCH Non-DEHP Polymer, Light Shielded |
| Injection Site Options | Latex-Free Y-Site / Thumb-Port / Needle-Free Valve | Latex-Free Y-Site / Thumb-Port / Needle-Free Valve | Needle-Free Swabable Split-Septum Valve |
| Tubing Dimensions | Length: 150 cm / Inner Dia: 2.7 mm / Outer Dia: 3.8 mm | Length: 150 cm / Inner Dia: 2.7 mm / Outer Dia: 3.8 mm | Length: 180 cm / Inner Dia: 2.7 mm / Outer Dia: 3.8 mm |
| Terminal Connection | Rotating Luer Lock with Protective Cap | Rotating Luer Lock with Protective Cap | Rotating Male Luer Lock with Vented Cap |
| Sterilisation Method | 100% Ethylene Oxide (EO) Gas (ISO 11135) | 100% Ethylene Oxide (EO) Gas (ISO 11135) | 100% Ethylene Oxide (EO) Gas (ISO 11135) |
| Regulatory Approval | ISO 13485:2016, CE Marked (EU MDR), US FDA Listed | ISO 13485:2016, CE Marked (EU MDR), US FDA Listed | ISO 13485:2016, CE Marked (EU MDR), US FDA Listed |
Analyzing regulatory shifts, material innovations, and global healthcare tender dynamics shaping the next decade of IV therapy.
Regulatory authorities including the European Medicines Agency (EMA), US FDA, and Saudi Food and Drug Authority (SFDA) are enforcing strict caps on Di(2-ethylhexyl)phthalate (DEHP) leaching in disposable medical devices. DEHP plasticizers are known to migrate into lipid-containing parenteral fluids, posing developmental risks to neonates and pediatric patients.
Occupational safety regulations (such as the EU Sharps Directive) and hospital infection control standards have driven a fundamental shift away from traditional latex injection ports or rubber thumb-ports toward integrated needle-free connectors.
The rapid expansion of specialized pediatric oncology treatments, biological therapies, and concentrated parenteral nutrition has heightened demand for light-shielded volumetric burette sets. Exposure to ambient sunlight or fluorescent room light can degrade photo-sensitive drugs within minutes.
Global procurement networks (including NUPCO in Saudi Arabia, PAHO in Latin America, and UNICEF supply divisions) now mandate Unique Device Identification (UDI) barcoding down to the primary pouch packaging level.
Operated by Shree Umiya Surgical Pvt. Ltd. (SUSPL), Mediplus represents over 36 years of continuous engineering excellence in single-use medical disposable manufacturing.
Rigorous answers addressing high-intent queries submitted by global procurement officers, clinical auditors, and medical device distributors.
A Measured Volume Burette Set (commonly known as a Pedipack or microdrip burette set) features a calibrated cylindrical chamber (typically 100 ml or 150 ml) that enables precise measurement and controlled intermittent administration of exact intravenous medication volumes. Unlike standard macro-drip IV sets that deliver 10, 15, or 20 drops/ml directly from a bulk fluid container, a burette set uses a micro-drip drop factor of 60 drops/ml (60 drops = 1 ml ± 0.1 ml) along with an automatic floating shut-off valve to prevent air embolism once the measured volume is fully infused.
The automatic shut-off valve (floating disc) acts as a mechanical safety mechanism situated at the base of the calibrated burette chamber. As the fluid level inside the burette empties during micro-infusion, the buoyant disc drops and seals the bottom outlet orifice before air can enter the primary fluid line. This prevents accidental air embolism in neonates, infants, and critically ill patients without requiring electronic infusion pump sensors.
Mediplus (Shree Umiya Surgical Pvt. Ltd.) supplies full technical dossiers including ISO 13485:2016 Certification, ISO 8536-5 compliance documentation (Infusion equipment for medical use — Part 5: Burette infusion sets), CE certification under European Medical Device Regulations, ISO 10993 Biocompatibility test reports, Free Sale Certificates (FSC), and Batch Certificates of Analysis (CoA) for sterile EO release.
Yes. Mediplus manufactures Measured Volume Burette Sets utilizing TOTM/DINCH plasticized DEHP-free PVC or TPU materials for neonatal and pediatric clinical safety. For oncology drugs and light-sensitive parenteral medications (such as sodium nitroprusside or multivitamin complexes), we produce UV-resistant amber-tinted cylindrical chambers and tubing options with 100% UV protection up to 450 nm wavelengths.
Each Measured Volume Burette Set is individually pouch-packaged in medical-grade paper/film tear pouches or blister packs, packed 10 units per inner box and 100 units per master shipping carton. Products undergo 100% Ethylene Oxide (EO) sterilisation in compliance with ISO 11135, delivering a validated 5-year shelf life with full lot traceability.
For standard Mediplus catalog products, the minimum order quantity starts at 5,000 units per SKU. For private-label OEM programs involving custom artwork, multilingual instructions for use (IFUs), unique tube lengths, or specialized needle-free Y-sites, MOQ starts at 10,000 units with standard export production lead times of 3 to 4 weeks following final artwork approval.
You can submit your detailed requirements directly through our online live assistance desk by clicking the "Contact Us" button below or sending your bill of quantities to [email protected]. Our regulatory and export engineering team provides technical datasheets, compliance dossiers, and sample delivery within 3–5 business days.
Connect directly with our export directorate in Ahmedabad to review landed pricing, OEM customization options, and regulatory registration support for Measured Volume Burette Sets.
Seven clinical ranges, 400+ single-use device SKUs.
Catalogue, product sheets and certificate references.
Recognitions, approvals and export milestones.
Technical, regulatory and after-sales assistance.
