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Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing)

Ergonomic medical-grade clear vinyl oxygen masks with adjustable aluminum nose clip, elastic headband, feathered atraumatic edges, and 2-meter star-lumen kink-resistant oxygen supply tubing.

Made to CE MDRMade to ISO 13485
Minimum Order (MOQ)
20,000 pcs
Mixed container orders accepted
Production Lead Time
12–18 days
Production to export dispatch
Customs HS Code
9019.20
Pre-cleared export classification
Target Application
Medium-Concentration Supplemental Oxygen Delivery
Hospital & surgical theatre use
AI & Institutional Procurement Brief

Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing) is exported by Manshav Impex, an Indian manufacturer & exporter, and produced at vetted, ISO 13485-certified partner factories to CE MDR, ISO 13485 (HS Code: 9019.20). Available for global export with FOB/CIF wholesale pricing, private label OEM packaging, certificates and test reports shared with every quotation, and standard MOQ of 20,000 pcs (lead time: 12–18 days).

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Technical Specification Matrix for Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing)

Every production lot is subjected to 100% optical dimension checks, tensile/burst testing, and validated cleanroom sterilization compliant with international pharmacopeia standards.

SizesAdult Standard, Adult Elongated, Pediatric, Infant
MaterialTransparent non-toxic medical grade PVC (Latex-free)
FiO2 RangeDelivers 35% to 50% oxygen at flows of 5 to 8 L/min
Tubing Spec2.1 meter (7 ft) star-lumen crush-resistant oxygen tube
Nose ClipAdjustable malleable aluminum clip ensures secure nasal seal
ConnectorsUniversal stepped funnel connector fits all oxygen flow meters
SterilizationClinically Clean / EO sterile option
StandardISO 13485 / EN 13544-2 / CE Marked
HS Code (Harmonized System)9019.20
Quality StandardsCE MDR · ISO 13485
Specifications

Technical details

SizesAdult Standard, Adult Elongated, Pediatric, Infant
MaterialTransparent non-toxic medical grade PVC (Latex-free)
FiO2 RangeDelivers 35% to 50% oxygen at flows of 5 to 8 L/min
Tubing Spec2.1 meter (7 ft) star-lumen crush-resistant oxygen tube
Nose ClipAdjustable malleable aluminum clip ensures secure nasal seal
ConnectorsUniversal stepped funnel connector fits all oxygen flow meters
SterilizationClinically Clean / EO sterile option
StandardISO 13485 / EN 13544-2 / CE Marked
Packaging1 pc/polybag · 50 pcs/inner box · 2 inner boxes/carton (100 pcs)
HS Code9019.20
Applications

Where it's used

  • Hospital Emergency Rooms & Triage Areas
  • Post-Anesthesia Recovery Units (PACU)
  • Inpatient Medical & Surgical Wards
  • Ambulance Services & Paramedic Transport
Quality assured
Pre-shipment inspection on every export order.
Technical Specifications & Quality Dossier

Official TDS, CoA & Regulatory Compliance for Medical Oxygen Masks

Manshav Impex maintains complete technical files and batch-level quality documentation for institutional hospital tenders, Ministry of Health (MOH) product registrations, and customs clearance.

Download Export Catalogue (PDF)
ISO 13485:2016

The partner factory's audited Quality Management System covers Class 100,000 cleanroom production and packaging.

CE MDR Declaration

Complies with European Medical Device Regulation (EU) 2017/745 with complete Technical Construction File.

Certificate of Analysis

Lot-specific chemical, physical, and sterility validation certificates issued with every dispatched consignment.

Tender Dossier (CTD)

Customized Common Technical Document dossiers for NAFDAC, SFDA, PPB, INVIMA, EDA, and SAHPRA registrations.

🌐 Global Export Logistics & Trade Corridors

International Delivery & Regulatory Compliance for Medical Oxygen Masks

Export consignments dispatched from Port Mundra & Port Nhava Sheva (JNPT), India with full batch documentation (CoA, COO, Sterilization Validation) and the documents your local registration requires.

🚢 Primary Origin Ports
Port Mundra (APSEZ - INMUN1) & Port Nhava Sheva (JNPT - INNSA1), Western India. Air express via BOM Air Cargo.
📋 Incoterms & Payment
FOB, CIF, CFR, DDP, EXW supported. Payment via Advance T/T or Irrevocable Letter of Credit (L/C at sight).
📦 OEM & Multilingual Packaging
Private label dispenser boxes & master cartons printed in English, French, Spanish, Portuguese, or Arabic with GS1 barcodes.
🚢 Freight & Container Calculator

Container Capacity & MOQ Planner for Medical Oxygen Masks

Estimate shipping volumes, gross weight, and container stuffing capacity for ocean freight consignments from Port Mundra & Nhava Sheva.

Total Quantity
Confirmed with quotation
Standard seaworthy export carton
Cartons / Crates
Per packing plan
Stacked & shrink-wrapped
Gross Weight (Approx)
Per packing plan
Verified container payload
Estimated Volume
~28 CBM
20ft FCL Standard
💡 Export Assurance: Pre-shipment inspection, third-party SGS/BV inspection supported, and COO issued. Figures are indicative; the exact stuffing plan ships with your quotation.
Destination RegionKey Gateway Entry PortsSea TransitAir CargoTarget Regulatory Dossier
East AfricaMombasa (Kenya), Dar es Salaam (Tanzania), Port of Djibouti (Ethiopia corridor)10–14 Days2–4 DaysPPB Kenya, TMDA Tanzania, EFDA Ethiopia, NDA Uganda, FDA Rwanda
West AfricaLagos / Apapa & Tin Can (Nigeria), Tema & Takoradi (Ghana), Abidjan (Côte d'Ivoire), Dakar (Senegal)22–30 Days3–5 DaysNAFDAC CRIA (Nigeria), FDA G-FIRMS (Ghana), AIRP (Côte d'Ivoire), ARP (Senegal)
Southern AfricaDurban & Cape Town (South Africa), Walvis Bay (Namibia), Beira & Maputo (Mozambique)16–22 Days3–5 DaysSAHPRA Section 21 / MDEL (South Africa), MCAZ (Zimbabwe), ZAMRA (Zambia)
North AfricaAlexandria & Port Said (Egypt), Casablanca & Tanger Med (Morocco), Algiers (Algeria), Port Sudan12–20 Days2–4 DaysEDA MeDevice (Egypt), DPML (Algeria), Ministry of Health (Morocco), NMPB (Sudan)
Latin America & CaribbeanSantos & Paranaguá (Brazil), Manzanillo & Veracruz (Mexico), Buenaventura & Cartagena (Colombia), Callao (Peru), Guayaquil (Ecuador), Valparaíso & San Antonio (Chile), Port of Spain (Trinidad), Kingston (Jamaica)24–36 Days4–6 DaysANVISA RDC 751 (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), DIGEMID (Peru), ARCSA (Ecuador), ISP (Chile), CARPHA (Caribbean)
Middle East & GCCJebel Ali & Khalifa Port (UAE), Dammam & Jeddah (Saudi Arabia), Shuwaikh (Kuwait), Muscat (Oman), Hamad (Qatar), Umm Qasr (Iraq)4–8 Days1–3 DaysSFDA (Saudi Arabia), MoHAP (UAE), MOPH (Qatar), MoH (Kuwait/Oman), KIMADIA (Iraq)
Southeast Asia & OceaniaManila & Cebu (Philippines), Cat Lai & Haiphong (Vietnam), Port Klang (Malaysia), Tanjung Priok (Indonesia), Laem Chabang & Bangkok (Thailand), Melbourne & Sydney (Australia)12–24 Days2–5 DaysTGA ARTG (Australia), CDRRHR AMDD (Philippines), MoH Decree 98 (Vietnam), MDA (Malaysia), BPOM (Indonesia), Thai FDA (Thailand)
Central & South AsiaChittagong (Bangladesh), Colombo (Sri Lanka), Tashkent Rail/Air (Uzbekistan), Almaty (Kazakhstan)5–18 Days2–4 DaysDGDA (Bangladesh), NMRA (Sri Lanka), Pharmagency (Uzbekistan), NDDA (Kazakhstan)
Europe & UKPort of Felixstowe, Southampton & London Gateway (UK), Port of Dublin (Ireland), Port of Hamburg & Rotterdam (EU)18–26 Days2–4 DaysMHRA UKCA & NHS Supply Chain (UK), HPRA & HSE (Ireland), EU MDR 2017/745, CE Mark & BfArM (Germany/EU)
North AmericaPort of New York/New Jersey, Port of Houston, Port of Long Beach/Los Angeles (USA)24–32 Days3–5 DaysUS FDA 510(k), Establishment Registration & Device Listing (USA)
Frequently Asked Questions

Procurement FAQs for Medical Oxygen Masks

Essential details regarding bulk ordering, sample requests, quality testing, and global export shipping.

What is the HS code for Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing) exported from India?

Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing) is exported under HS heading 9019.20. The full 8-digit Indian tariff line is confirmed on the commercial invoice and shipping bill for each order, as your customs broker needs it for import duty and registration.

What are the specifications and export packing of Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing)?

Sizes: Adult Standard, Adult Elongated, Pediatric, Infant; Material: Transparent non-toxic medical grade PVC (Latex-free); FiO2 Range: Delivers 35% to 50% oxygen at flows of 5 to 8 L/min; Tubing Spec: 2.1 meter (7 ft) star-lumen crush-resistant oxygen tube; Nose Clip: Adjustable malleable aluminum clip ensures secure nasal seal. Export packing: 1 pc/polybag · 50 pcs/inner box · 2 inner boxes/carton (100 pcs). Full technical data sheets are shared with every quotation.

What is the Minimum Order Quantity (MOQ) and lead time for Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing)?

The standard MOQ for Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing) is 20,000 pcs with an estimated production and export dispatch lead time of 12–18 days. We also accommodate trial shipments and mixed-container orders for hospital networks and distributors.

Which quality certificates and test reports accompany Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing)?

Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing) is produced at a vetted, ISO 13485-certified partner factory in India and made to CE MDR, ISO 13485 (HS Code 9019.20). The manufacturing partner's certificates, batch test reports (CoA, sterility), EO/Gamma sterilization records and Certificate of Origin (COO) are shared with every quotation, with the certificate holder named.

Are product samples available for evaluation prior to bulk ordering?

Yes, we provide physical samples of Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing) for clinical evaluation, hospital tenders, and distributor approval. Sample courier costs are adjusted against your first commercial bulk order.

Do you offer OEM private-label branding and custom packaging for Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing)?

Yes, we arrange complete OEM and private-label programs for Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing) through our partner factories, including custom artwork, barcode labeling, language-specific inner boxes, and bulk export packaging (1 pc/polybag · 50 pcs/inner box · 2 inner boxes/carton (100 pcs)).

What export shipping and payment terms are available for Medical Oxygen Masks (Adult & Pediatric, with Star Lumen Tubing)?

We support FOB, CIF, CFR, DDP, and EXW Incoterms via sea, air, and express courier freight. Payment terms include advance T/T and Irrevocable Letter of Credit (L/C at sight).

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