Pediatric Urinary Bag

Pediatric Urinary Bag is a single-use medical device specifically designed for urine collection and storage in infants, toddlers, and children. Tailored to the anatomical characteristics and low urine output of pediatric patients, it is constructed from ultra-soft, medical-grade PVC/PE material, featuring a compact capacity, leak-proof structure, child-friendly design, and secure connection options. Sterilized and ready for immediate use, it is widely applied in hospitals, pediatric wards, neonatal intensive care units (NICUs), clinics, and home care settings, ensuring safe, comfortable, and hygienic urine management for children of all age groups (newborns to adolescents).

The bag's compact and lightweight design minimizes discomfort for children, while the ultra-soft, skin-friendly material reduces irritation to delicate pediatric skin. Transparent bag body with clear, large-scale mL graduations enables quick and accurate urine output measurement, critical for clinical monitoring of fluid balance and renal function in children. Depending on age and use scenarios, it offers two main designs: adhesive-type (for infants/newborns, with gentle medical adhesive to attach to the perineal area) and leg strap-type (for mobile children, with adjustable soft elastic straps to secure around the leg). The integrated anti-reflux valve prevents urine backflow, significantly reducing the risk of urinary tract infections (UTIs) in vulnerable pediatric patients. Each unit is individually sterilized via ethylene oxide (EO) gas, complying with ISO 13485, CE, and NMPA medical device standards, guaranteeing safe clinical application.

Product Properties

 

 

1. Pediatric-Specific Design: Compact capacity and lightweight structure fit children's body characteristics, avoiding bulk and discomfort; two design types meet the needs of non-mobile infants and active children.
2. Superior Skin-Friendly Performance: Ultra-soft medical-grade material and hypoallergenic adhesive (for adhesive-type) minimize irritation to delicate pediatric skin, reducing the risk of redness or allergic reactions.
3. Anti-Reflux & Leak-Proof Protection: Integrated anti-reflux valve blocks urine backflow, lowering UTI risk; reinforced seams and secure design prevent leakage, maintaining hygiene.
4. Easy Monitoring & Operation: Transparent bag body with large-scale graduations enables quick urine output checks; adhesive-type is easy to attach and remove, leg strap-type with adjustable straps ensures a secure fit.
5. Safe & Reliable: Latex-free and non-toxic material complies with pediatric medical standards; individual EO sterilization ensures sterility and avoids cross-infection.
6. Sterile & Ready-to-Use: Individual EO-sterilized packaging eliminates pre-procedure preparation, facilitating quick deployment in clinical or home settings.

 

Application

 

 

1. Neonatal Intensive Care Units (NICUs): Essential for newborns and premature infants requiring urine output monitoring, with adhesive-type design ensuring gentle and secure collection.
2. Pediatric Hospital Wards: Used for children with urinary incontinence, indwelling catheters, or postoperative care, supporting clinical monitoring of fluid balance and recovery.
3. Home Care: Suitable for children with chronic conditions (e.g., neurogenic bladder) or those recovering from urological surgery, enabling convenient and hygienic urine management at home.
4. Pediatric Clinics: Temporary urine collection for urine tests or short-term monitoring, providing a non-invasive and comfortable solution for young patients.
5. Emergency Care: Urine collection for sick or injured children in emergency departments, supporting rapid clinical assessment.

Certifications: Complies with ISO 13485, CE, and NMPA medical device standards. Each production batch undergoes strict quality testing, including: biocompatibility evaluation (cytotoxicity, skin irritation, sensitization), leak-proof performance testing (pressure and duration validation), anti-reflux valve function verification, adhesive safety testing (for adhesive-type), strap elasticity and durability testing (for leg strap-type), dimensional accuracy checks (capacity, connector size, strap length), and sterility validation (EO residual content ≤10 μg/g). A unique batch number is assigned for full production and distribution traceability, and a detailed Instruction for Use (IFU) is included with each package, specifying usage steps, size selection, and safety precautions.

1. Packing: Individual sterile paper-plastic composite packaging with peel-open seal; each package is clearly labeled with product name, capacity, design type (adhesive/leg strap), batch number, sterilization date, and expiration date. Bulk transport in sturdy corrugated cartons with anti-crush dividers to prevent bag deformation or damage to valves/adhesives/straps.
2. Storage: Store in a clean, dry, well-ventilated environment with temperature 10℃~40℃ and relative humidity ≤80%. Avoid direct sunlight, high heat (above 50℃), high humidity, contact with sharp objects, or corrosive substances. Do not stack heavy objects on packaging, and keep sealed until immediately before use.
3. Handling: For single-patient use only-do not reuse, reprocess, or share to prevent cross-infection. Before use, inspect the package for tears, damage, or expiration; discard immediately if sterility is compromised. For adhesive-type: Clean and dry the infant's perineal area before application, avoid stretching the adhesive excessively; remove gently after use. For leg strap-type: Adjust straps to fit snugly (not too tight) to avoid restricting circulation. Empty the bag promptly when it reaches 2/3 capacity to prevent overfilling and leakage. After use, dispose of the bag in accordance with medical waste management regulations.
4. Transportation: Transport in accordance with national and international medical device transportation regulations. Protect from violent collision, compression, moisture, and direct sunlight. Avoid transportation with toxic, harmful, or corrosive substances. Ensure the transportation environment temperature is between -10℃~50℃ to maintain product integrity and sterility.

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.

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