A silicon manual resuscitator is a reusable bag-valve-mask (BVM) device engineered for emergency respiratory support, featuring a resilient silicone resuscitation bag and silicone face mask. Designed with ergonomics and durability in mind, it delivers reliable manual ventilation for patients with respiratory arrest or inadequate breathing, and its autoclavable property enables safe repeated clinical use across healthcare settings. Widely trusted in hospitals, clinics, emergency care services, and intensive care units, it serves as a core life-saving tool for on-demand respiratory assistance when mechanical ventilation is unavailable or impractical.
Crafted from high-quality medical-grade silicone, the resuscitator offers superior resilience and flexibility compared to PVC alternatives-maintaining its shape and performance after repeated use and autoclaving cycles. The ergonomic design of the resuscitation bag ensures a comfortable grip, reducing hand fatigue for healthcare providers during prolonged resuscitation efforts. Both the bag and face mask are transparent, allowing visual monitoring of ventilation volume, patient lip color, and facial expressions to assess resuscitation effectiveness. It is equipped with a precision one-way valve system that prevents exhaled gas from re-entering the bag, ensuring a fresh supply of air or supplemental oxygen with each breath. The silicone face mask features a soft, contoured edge that conforms to diverse facial anatomies, creating a leak-proof seal to maximize ventilation efficiency. Compatible with standard oxygen sources (via an integrated oxygen inlet port), it can deliver up to 100% supplemental oxygen to meet critical patient needs. Each unit undergoes rigorous quality testing, including leakage verification, valve functionality checks, autoclavability validation, and biocompatibility assessments, complying with ISO 13485, CE, and NMPA standards for safe and long-lasting clinical use.
Product Specification
|
Item |
Description |
|
Application |
Emergency manual ventilation for patients with respiratory arrest or inadequate breathing |
|
Type |
Reusable bag-valve-mask (BVM) device |
|
Material |
Medical-grade silicone |
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Core Components |
Silicone resuscitation bag, silicone face mask, one-way valve system, oxygen inlet port |
|
Ventilation Capacity |
Adult: 600-1200mL; Pediatric: 300-600mL; Infant: 150-300mL |
|
Oxygen Compatibility |
Accepts oxygen flow rates of 5-15 L/min |
|
Mask Sizes |
Adult, pediatric, infant |
|
Reusability |
Reusable |
|
Sterility |
Non-sterile |
|
Shelf Life |
5 years |
Product Properties
- Reusable & Autoclavable: Withstands repeated autoclaving (134℃) for safe, cost-effective long-term clinical use.
- Resilient Silicone Construction: Maintains flexibility and structural integrity after frequent use and sterilization.
- Ergonomic Design: Contoured resuscitation bag grip reduces hand fatigue during prolonged resuscitation.
- Transparent Visibility: Clear silicone bag and mask enable real-time monitoring of ventilation volume and patient status.
- Leak-Proof Seal: Soft, conformable mask edge adapts to facial anatomy, ensuring efficient air/oxygen delivery.
- One-Way Valve System: Prevents gas re-entry, preserving fresh air/oxygen supply and minimizing contamination risks.
Application
Hospital & ICU Settings:
Resuscitation of patients with respiratory failure due to trauma, cardiac arrest, or severe illness.
01
Emergency Medical Services (EMS):
Ventilation support during patient transport and pre-hospital emergency care.
02
Operating Rooms:
Backup ventilation for patients during anesthesia induction, emergence, or equipment failure.
03
Pediatric & Neonatal Care:
Size-adapted resuscitators for infants and children requiring gentle, effective ventilation.
04
Long-Term Care Facilities:
Emergency respiratory support for residents with chronic respiratory conditions prone to acute exacerbations.
05
Physical Properties
|
Item |
Specification |
|
Operating Temperature |
5℃~50℃ |
|
Material Hardness |
Resuscitation bag: Shore A 45-50; Mask: Shore A 30-35 |
|
Product Weight |
Adult: 250-300g; Pediatric: 180-220g; Infant: 100-150g |
|
Mask Inner Diameter |
Adult: 8-10cm; Pediatric: 5-7cm; Infant: 3-5cm |
|
Valve Opening Pressure |
1-2 cmH₂O |
|
Oxygen Inlet Port Diameter |
6mm |
|
Autoclave Cycle Resistance |
≥100 cycles |
QA&QC
Certifications: Complies with ISO 13485, CE, and NMPA medical device standards. Each production batch undergoes leakage testing to ensure airtightness, valve functionality verification to confirm one-way flow, ventilation capacity checks to guarantee effective air delivery, autoclavability validation to confirm resilience under sterilization conditions, and biocompatibility assessments (cytotoxicity, sensitization) for medical-grade silicone. Unique batch number is assigned for full production and distribution traceability, and detailed Instruction for Use (IFU) and Material Safety Data Sheet (MSDS) are provided.
Packing,Storage,Handling and Transportation
Packing: Individual PE bag packaging with foam cushioning; bulk transport in sturdy corrugated cartons with anti-collision protection.
Storage: Store in a clean, dry, well-ventilated environment (temperature 5℃~50℃, relative humidity ≤70%). Avoid direct sunlight, high heat, or contact with sharp objects and corrosive substances. Keep the device in its original packaging when not in use.
Handling: Reusable-sterilize via autoclaving (134℃) before first use and after each patient use. Inspect for cracks, tears, or valve malfunctions before and after sterilization. Ensure the mask forms a proper seal on the patient's face; avoid using abrasive cleaners that may damage the silicone surface.
Transportation: Transport in accordance with medical device regulations. Protect from violent collision, extreme temperatures, or moisture to preserve structural integrity and performance.
Reasons for choosing us
Zhejiang Mediunion Healthcare Group Co. Ltd. (a branch of Evergrand Healthcare Group, founded in 2014) is located in Ningbo City, Zhejiang Province - enjoying an excellent location and convenient transportation. Our business covers medical device manufacturing & sales, plus investments in nursing homes, dental clinics, specialist hospitals and medical care services. Our products are sold worldwide, and we've won global consumer recognition with high-quality goods and comprehensive after-sales service.
Diversified Product Portfolio
Our product range includes disposable medical consumables, medical equipment and non-woven products (e.g. dental supplies, respiratory care items). This diverse lineup caters to the needs of medical institutions, clinics and other clients.
Reliable Supply & Collaboration
We have rich industry experience and partner with over 600 factories. These partners are equipped with advanced production equipment and skilled frontline staff, enabling us to produce customized products/components as per specific requests.
Strict Quality Assurance
We prioritize innovation & quality, backed by the ISO 13485:2016 quality management system. Strict control runs through raw material procurement, mass production, process management and finished product release. Our professional services (production control, order follow-up, delivery) also set us apart.
Certificate
FAQ
Q:Are you a manufacturer or trading company?
A:We are a professional manufacturer with our own production facilities, R&D team, and quality control department. We do not act as a trading company-this allows us to have full control over product quality, production lead times, and customization capabilities, while offering competitive pricing directly to our customers.
Q:How long have you been producing this product?
A:We have been specializing in the production of this specific medical product for over 12 years. During this period, we have accumulated rich experience in process optimization, quality improvement, and regulatory compliance, and have served hundreds of customers worldwide with a proven track record of reliability.
Q:Do you support custom specifications or OEM/ODM?
A:Yes, we fully support custom specifications, OEM (Original Equipment Manufacturing), and ODM (Original Design Manufacturing) services. Our R&D and engineering teams can work with you to customize product dimensions, materials, functions, packaging, and labeling to meet your specific requirements. We also provide technical support throughout the customization process to ensure compliance with local regulations.
Q:What factors affect your pricing (volume, packaging, certifications)?
A:The key factors affecting our pricing include:
Order Volume: Larger order quantities qualify for higher volume discounts;
Customization Requirements: Specialized specifications, packaging, or labeling may incur additional costs;
Certifications: Products requiring additional regional certifications (beyond standard FDA/CE/ISO) may have slightly higher pricing due to certification costs;
Packaging Type: Premium packaging (e.g., sterile packaging, specialized tender packaging) or small-batch retail packaging may affect pricing;
Lead Time: Urgent orders requiring expedited production or shipping may involve additional fees.
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