Precision-engineered hospital-grade disposables manufactured under ISO 13485 cleanroom standards
In high-acuity respiratory care, delivering exact, reproducible fraction of inspired oxygen (FiO2) is paramount. The Venturi Mask (Air-Entrainment Mask) remains the gold-standard non-invasive respiratory device for managing patients with Chronic Obstructive Pulmonary Disease (COPD), acute hypercapnic respiratory failure, and post-extubation hypoxemia.
Unlike standard nasal cannulas or simple oxygen masks where delivered FiO2 fluctuates dramatically with patient respiratory rate, tidal volume, and peak inspiratory flow, Venturi systems operate on strict hydrodynamic mechanics governed by Bernoulli's Principle and the Venturi Effect.
As pressurized oxygen passes through a constricted nozzle (orifice) within the mask's calibrated dilator, its velocity increases rapidly while its static pressure drops below ambient atmospheric pressure. This localized pressure gradient draws a precise, predictable volume of room air through lateral entrainment ports, producing a total gas flow that exceeds the patient’s peak inspiratory demand.
Requires 2 L/min O2 flow. Delivers high total entrainment air ratio (25:1). Ideal for hypoxic COPD patients susceptible to hypercapnic drive suppression.
Requires 4 L/min O2 flow. Entrainment ratio (10:1). Provides steady low-dose oxygenation with controlled carbon dioxide retention risk.
Requires 6 L/min O2 flow. Entrainment ratio (7:1). Calibrated for moderate acute respiratory insufficiency requiring stable gas concentration.
Requires 8 L/min O2 flow. Entrainment ratio (5:1). Standard post-anesthesia recovery and emergency ward stabilization protocol.
Requires 10 L/min O2 flow. Entrainment ratio (3:1). Provides elevated continuous oxygenation for moderate-to-severe hypoxemia.
Requires 12-15 L/min O2 flow. Entrainment ratio (1.7:1). High-concentration delivery prior to mechanical ventilation escalation.
By guaranteeing that the total gas delivery rate (entrained air + oxygen input) consistently exceeds 30–40 L/min, our Venturi masks prevent rebreathing of exhaled CO2 and neutralize atmospheric dilution caused by mouth-breathing or tachypnea.
Israel's healthcare sector is globally recognized for its technological sophistication, centralized administration, and rigorous quality benchmarks. Procurement officers, hospital purchasing managers, and medical device importers operating within Israel must navigate a highly structured regulatory and clinical ecosystem.
All medical disposables imported into Israel must obtain approval from AMAR (Astar - Medical Devices Division of the Israeli Ministry of Health). AMAR alignment requires comprehensive technical files, proof of ISO 13485 certification, and valid CE Certificates (under EU MDR 2017/745 guidelines) or US FDA 510(k) clearances.
Supplying institutional buyers like Clalit Health Services, Maccabi Healthcare Services, Meuhedet, and Leumit requires strict unit-cost efficiency, low defect rates, and bulk packaging compliance.
Tier-1 academic medical centers such as Sheba Medical Center (Tel Hashomer), Ichilov (Tel Aviv Sourasky), and Rambam Health Care Campus demand medical-grade materials, DEHP-free biocompatibility, and ergonomic patient comfort.
Institutions like Magen David Adom (MDA) and IDF Medical Corps maintain strategic emergency reserves. Products must feature extended shelf-life (5-year ETO sterile packaging integrity) and robust outer cartons capable of rapid deployment.
Due to Israel's geographic positioning, seamless maritime logistics to Port of Ashdod and Port of Haifa, alongside expedited air freight through Ben Gurion International Airport (TLV), are vital for uninterrupted inventory management. Foreign original equipment manufacturers (OEMs) must provide container load optimization, palletized packaging (EUR-pallets), and complete customs documentation (Certificate of Origin, Free Sale Certificate).
Our Venturi Mask kits are engineered using non-toxic, transparent, medical-grade PVC polymers designed to eliminate facial pressure sores while providing clear visual monitoring of patient cyanosis or vomit risk.
| Parameter / Feature | Angiplast Technical Specification | Clinical Advantage for Israeli Procurement |
|---|---|---|
| Biocompatibility | 100% Phthalate-Free / DEHP-Free Medical PVC | Prevents endocrine disruption; fully compliant with EU MDR and Israeli MoH safety mandates. |
| Tubing Architecture | 2.1m Star-Lumen Kink-Resistant Tubing | Ensures continuous gas flow even if tubing is bent, twisted, or accidentally stepped on. |
| Sterilization Standard | Ethylene Oxide (ETO) Sterile / Class 10k Cleanroom | Zero bioburden; validated residual ETO levels well below ISO 10993-7 thresholds. |
| Facial Fit & Strap | Ergonomic Under-Chin Design with Adjustable Nose Clip | Minimizes oxygen leakage around eyes; reduces risk of patient conjunctivitis. |
| Dilator Accuracy | Color-Coded Precision Jet Orifices (±1% FiO2 Tol.) | Eliminates clinician error during rapid FiO2 adjustment in ICU and ED settings. |
| Connectors & Adaptors | Universal 22mm / 15mm ISO Tapered Fittings | Seamless integration with hospital wall flowmeters, humidifiers, and aerosol kits. |
Operating a vertically integrated manufacturing complex spanning over three decades since 1994 in Ahmedabad, India, Angiplast Pvt. Ltd. stands as a global leader in single-use medical polymer disposables. Exporting over 80% of total output across 52+ countries, our infrastructure is built to support high-volume private label (OEM) and Contract Development & Manufacturing Organization (CDMO) partnerships.
All component molding, tube extrusion, mask forming, and pouch sealing occur within certified Class 10,000 (ISO Class 7) cleanrooms, maintaining uncompromising hygienic controls.
Equipped with state-of-the-art injection and blow molding machinery alongside an in-house tool room, allowing rapid custom design modifications for local market specifications.
Our fully automated ethylene oxide sterilization facility validates each batch against rigorous biological indicators, guaranteeing absolute sterility for emergency reserve storage.
Full adherence to ISO 13485:2016 standard. We provide complete technical construction files, stability data, and bioburden reports required for AMAR registration.
Support for Hebrew/English bilingual packaging artwork, GS1 DataMatrix UDI barcoding, and custom kit assembly for hospital tender compliance.
Economies of scale coupled with direct Indian manufacturing supply chains enable Israeli medical importers to optimize tender margins without sacrificing quality.
As the Israeli medical sector expands its digital health and patient-centric care models, several structural trends are reshaping respiratory disposable procurement:
1. Shift Toward Eco-Conscious & Recyclable Polymers: Israeli health authorities are increasingly prioritizing sustainability. Future tenders will favor manufacturers utilizing recyclable TPE (Thermoplastic Elastomers) or reduced-weight PVC formulations that lower medical waste incineration impact.
2. Increased Strategic Stockpiling: Lessons learned from global pandemic disruptions and regional geopolitical realities have prompted Israeli Ministry of Health procurement directors to mandate 6-to-12-month domestic buffer stocks for critical airway and oxygen therapy disposables.
3. Universal UDI Traceability: Full integration of Unique Device Identification (UDI) barcodes on individual pouch packaging is becoming mandatory for automated inventory tracking within Clalit and government hospital logistics hubs.
Yes. Our manufacturing facilities operate under ISO 13485 QMS, and our products carry valid CE certification. We provide complete technical documentation dossiers, sterilisation validation summaries, and Free Sale Certificates (FSC) necessary to facilitate smooth AMAR registration in Israel.
OEM and private-label MOQs depend on the product SKU and custom packaging artwork specifications. Typically, baseline orders start at one full production lot per SKU. Our export desk collaborates closely with distributors to optimize ocean container loading (20ft/40ft FCL) or air freight shipments.
Standard packaging includes individually sealed, medical-grade peelable ETO pouches. For strategic emergency stockpiles, we offer reinforced outer cartons with inner moisture-barrier polybags designed for extended shelf-life retention (up to 5 years under controlled warehouse conditions).
Absolutely. All our respiratory and airway products are manufactured using 100% latex-free components. We explicitly offer DEHP-free medical PVC options complete with laboratory material testing reports upon request.
Production lead time typically ranges between 3 to 4 weeks following sample approval and order confirmation. Maritime transit time from West Coast India ports (Jawaharlal Nehru Port/Mundra) to Ashdod or Haifa ports is generally 14 to 20 days.
Yes, we provide complimentary sample kits containing our full range of color-coded Venturi dilators and mask configurations to accredited medical distributors, biomedical engineers, and hospital procurement officers for evaluation.
Streamline your medical disposable supply chain for the Israeli market. Contact our technical export team today to receive product catalogs, sample evaluation kits, and competitive FOB/CIF quotation terms.
Inquire Now
