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Medical Consumables two piece skin barriers providing secure interface between stoma and pouch with flexible flange sizes

Name: Medical Consumables two piece skin barriers providing secure interface between stoma and pouch with flexible flange sizes
Brand: Henan Aile Industry CO.,LTD.
SKU: Two-piece
Availability: InStock

Brand Name:	AILE
Model Number:	Two-piece
MOQ:	2000pcs
Price:	negotiation
Payment Terms:	L/C, T/T
Supply Ability:	100000 pieces per Month

Detail Information

Product Description

Detail Information

Place of Origin:

China

Certification:

CE ISO

Product Name:

Two-Piece Skin Barrier

Size:

Max Cut 57mm,Skin Barrier Diameter 108*108mm

Material:

Medical Hydrocolloid And Spunlance

Shelf Life:

3 Years

Instrument Classification:

Class I

Package:

5pcs/box, 40boxes/carton

OEM:

Accept OEM

Sample:

Free

Packaging Details:

blister bag

Supply Ability:

100000 pieces per Month

Product Description

Product Description

Two-piece skin barriers are medical devices designed to serve as the adhesive base plate for two-piece ostomy systems, creating a secure interface between the stoma and the detachable collection pouch. This two-piece system allows the skin barrier to remain in place on the abdomen while the pouch can be removed and replaced independently, offering greater flexibility and convenience for ostomy management. Model 7202 features a square shape design with a 45 flange, providing a strong and reliable connection for compatible ostomy bags. This model can also be manufactured with 45, 57, or 70 flange options to meet different clinical needs and user preferences. Each unit is individually packaged in a PVC blister package for hygiene and convenience. The max cut of 45mm accommodates various stoma sizes, while the medical hydrocolloid material ensures gentle adhesion and skin protection.

Company Profile

Henan Aile Industrial Co., Ltd. is a professional manufacturer and supplier of medical consumables, dedicated to providing high-quality ostomy care products to customers worldwide.

Head Office: R3511, NO. 2, Building 2, Yonghe Longzi Lake Central Plaza, between Ping'an Avenue and Xiuye Street, Zhengdong New District, 450000 Zhengzhou City, Henan Province, PEOPLE'S REPUBLIC OF CHINA

Factory Address: No. 1 Dongtang Road, Zhenlu Town, Tianning District, 213115 Changzhou, Jiangsu, PEOPLE'S REPUBLIC OF CHINA

Regulatory Compliance and Certifications

Our skin barriers are manufactured in compliance with international medical device quality standards. Our quality management system is certified as follows.

Applied Standard(s): ISO 13485:2016 (EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021) Medical devices - Quality management systems - Requirements for regulatory purposes

Certificate No.: Q6 099373 0009 Rev.

All products meet CE marking requirements for sale within the European Economic Area (EEA) and other regulated markets.

Product Features:

Square Shape Design: The skin barrier features a square shape that provides a broad adhesive surface area and stable attachment, offering a secure fit around the stoma.

Multiple Flange Options: This model is equipped with a 45 flange as standard, and can be manufactured with 45, 57, or 70 flange options to match different ostomy bag systems and user needs.

Leak-Proof Seal: The medical hydrocolloid barrier creates a strong, leak-proof seal around the stoma, preventing effluent from contacting the skin and reducing the risk of irritation and infection.

Flexible Sizing: With a max cut of 45mm, the barrier can be customized to fit various stoma sizes and shapes, ensuring a personalized and secure fit for different patients.

Soft and Skin-Friendly Material: Made from medical hydrocolloid that is gentle on the skin, hypoallergenic, and breathable, minimizing the risk of allergic reactions and skin maceration.

Individual PVC Blister Packaging: Each skin barrier is sealed in an individual PVC blister package, ensuring sterility, hygiene, and convenient storage until use.

Release Film Backing: Features a release film printing line base material that allows for easy and precise application, preventing the barrier from sticking to itself during placement.

Product Benefits:

Improved Quality of Life: Allows individuals with ostomies to manage their condition discreetly and maintain an active lifestyle with confidence, as pouches can be changed without disturbing the skin barrier.

Skin Protection: The hydrocolloid barrier protects the peristomal skin from effluent exposure, moisture, and mechanical irritation, promoting healthy skin integrity.

Convenience and Flexibility: The two-piece design enables quick and easy pouch changes without removing the adhesive base, saving time and reducing skin trauma from frequent barrier changes.

Cost-Effective: Users can replace the pouch as needed while keeping the same barrier in place for several days, reducing overall product consumption and cost.

Customizable Packaging: All packages can be customized to meet specific market and branding requirements.

Steps for Usage:

Wipe the stoma and the surrounding skin with warm water and dry thoroughly. Remove any hardened keratinized skin and stains, keeping the skin around the stoma clean and dry.
Measure the size of the stoma with the measuring card supplied. Do not touch the stoma with your fingers while measuring.
According to the measured size and shape of the stoma, cut an opening on the skin barrier film. The hole diameter is usually 2mm bigger than the stoma diameter. Max cut: 45mm.
Peel the protective release paper from the skin barrier and stick aiming at the stoma. Carefully paste up from the middle towards the outside, ensuring there are no wrinkles or air bubbles.
In order to make stickup secure, especially in areas and seasons with low temperature, you should press the pasted part with your hands for several minutes. In turn, the hydrocolloid flange could increase viscosity with the rising temperature.
Once the barrier is firmly in place, align the flange on the ostomy bag with the barrier flange and press together until you hear or feel a click, indicating a secure lock.

To remove the pouch, press the release tabs on the flange and gently pull the pouch away from the barrier, leaving the skin barrier attached to the body.

Product Information:

Product Name: Two-piece skin barrier with square shape Model: 7202 Brand: Henan Aile Industrial Co., Ltd. Flange: 45 (can be manufactured as 45, 57, 70 flange) Max Cut: 45mm Skin Barrier Size: 108x108mm Barrier Material: Medical hydrocolloid Printing Line Base Material: Release film Box Size: 155x155x35mm Carton Size: 380x320x330mm Carton Specification: 5pcs/box, 40boxes/carton Application Scope: Suitable for people with colostomy, ileostomy, or urostomy using two-piece ostomy systems Expiry Date: Three years Storage Condition: Store in a cool, clean and dustless environment, away from direct sunlight Note: Follow a doctor's advice. Wipe the skin around the stoma before wearing the skin barrier, in order to keep the skin dry, and ensure that the skin barrier will remain sticky. Do not arbitrarily discard it after use.

Indications:

Two-piece skin barriers are indicated for individuals who have undergone an ostomy surgery, which may be necessary for various reasons, including:

Colorectal cancer Inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis Diverticular disease Rectal prolapse Bladder cancer Neurogenic bladder dysfunction Birth defects

Contraindications:

There are no known contraindications to the use of skin barriers. However, individuals with skin sensitivities or allergies to specific materials should consult with a healthcare professional to determine the most suitable type of skin barrier for their needs.

Precautions:

Proper skin care around the stoma is essential to prevent irritation and infection.

Skin barriers should be changed regularly, typically every 3 to 7 days, or as directed by a healthcare professional.

Ensure the skin around the stoma is completely dry before application to guarantee optimal adhesion of the hydrocolloid barrier.

Do not overstretch or apply excessive pressure during application, as this may cause skin damage or compromise the seal.

Individuals should be educated on the proper use and maintenance of their skin barrier to ensure optimal comfort and hygiene.

Inspect the peristomal skin regularly for signs of irritation, redness, or breakdown, and consult a healthcare professional if any issues arise.

Tags:

Medical Consumables Surgical Consumables Medical Device Consumables Ostomy Care Products Two-Piece Ostomy System Skin Barrier Flange Base Plate

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Medical Consumables two piece skin barriers providing secure interface between stoma and pouch with flexible flange sizes

Medical Consumables two piece skin barriers providing secure interface between stoma and pouch with flexible flange sizes