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[Production Filing Certificate Number] Su Yang Food and Drug Administration Medical Device Production Filing No. 20210006

【Medical Device Filing Certificate Number】 Su Yang Equipment Preparation 20220517

[Product Technical Requirements Number] Su Yang Equipment Preparation 20220517

[Product Name] Negative-pressure drainage device

【Specifications and Model】 Blue, white

[Product Performance, Main Structural Components, or Ingredients]

The negative-pressure drainage device consists of a device body, a spring, an adjustment assembly, a connecting fitting, a connecting tube, a flow-control clamp, a protective cap, and a drainage bag. It is supplied non-sterile. It does not include a negative-pressure pump, a manual negative-pressure source (negative-pressure bulb), or drainage catheters intended for insertion into the body. The negative-pressure drainage device is available in two colors—white and blue—and in two capacity options: white units are offered in 1,000 mL and 2,000 mL capacities, while blue units are available only in a 1,000 mL capacity.

【Scope of Application】

When used for clinical negative-pressure drainage, it is connected to the drainage catheter inserted into the body, serving as a medium for transmitting negative pressure and guiding and collecting the drainage fluid.

【Instructions for Use】

1. This product is suitable for applications requiring drainage via negative pressure; 2. Connect the imported, dedicated negative-pressure connector; 3. Adjust the regulator.

Keywords:

Negative-pressure drainage device

The negative-pressure drainage device consists of a device body, a spring, an adjustment assembly, a connecting joint, a connecting tube, a flow-control clamp, a protective cap, and a drainage bag. It is supplied non-sterile. It does not include a negative-pressure pump, a manual negative-pressure source (negative-pressure bulb), or drainage catheters intended for insertion into the body. The negative-pressure drainage device is available in white and blue; the white version comes in two capacities—1,000 mL and 2,000 mL—while the blue version is available only in 1,000 mL.

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Jiangsu Kebang Bioscience Co., Ltd.

Phone:+86-514-82122999

Email:56608909@qq.com

Address: Yangzhou Health and Medical Industry Park, Touqiao Town, Guangling District, Yangzhou City

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