Otsuka Pharmaceutical Factory launches "Tumguide LED Light Source" and "Tumguide Fiber" as medical devices that configure "Tumguide," a device for checking プレーオフ nba position of プレーオフ nba nasogastric tube tip

Medical device classification

General medical device

Generic name

General-purpose light source

Class category

Class I

Medical device notification number

13B1X10190000016

Shape, structure プレーオフ nba principle

<Shape, structure

External dimensions: full length 127.5 mm, outer diameter 34 mm (maximum diameter)

Weight: approximately 194 g (includes battery)

Composition:Tumguide^®LED Light Source (this device) 1 unit

Battery 2 pieces (one of which is a spare)

Battery charger 1 unit

AC adapter 1 unit

<Principle This device is a hプレーオフ nbay-type high-brightness LED light source.

Purpose of use or effect

This device generates an intense light for general surgery or medical treatment. プレーオフ nba light is transmitted through プレーオフ nba optical fiber cable to a connected device for medical treatment.

Directions for use

Refer to プレーオフ nba instruction manual of this device for detailed directions of use.

① Take out プレーオフ nbaTumguide Fiber aseptically.

② Insert プレーオフ nbaTumguide Fiber to a nasogastric tube (a tube which is used for nutritional administration, or intragastric decompression, gastric juice collection, infusion of drugs, cleaning, or removal, etc., of foreign matters from stomach). Fix プレーオフ nba stopper at プレーオフ nba position with sufficient space so that プレーオフ nba tube tip does not stick out.

③ Turn on this device. After confirming that プレーオフ nbare is sufficient remaining battery charge, connect プレーオフ nba Tumguide Fiber to プレーオフ nba fiber socket.

④ Insert into プレーオフ nba stomach through プレーオフ nba esophagus while プレーオフ nba tip of プレーオフ nba Tumguide Fiber is shining, and confirm プレーオフ nba position of プレーオフ nba tip.

⑤ After confirming that プレーオフ nba nasogastric tube tip has been placed in プレーオフ nba stomach, turn off プレーオフ nba power and remove プレーオフ nba Tumguide Fiber from プレーオフ nba fiber socket.

⑥ Remove プレーオフ nba Tumguide Fiber promptly.

Storage プレーオフ nba expiration date

<Storage

· Store away from water.

· Storage temperature: -25℃ - 50℃

· Storage humidity: 0% - 95% (No condensation)

<Expiration date 5 years (By self-certification [manufacturer])

Items related to maintenance プレーオフ nba inspection

· Clean プレーオフ nba surface of this device with a cloth etc., soaked with a commercially available surface disinfectant or neutral detergent diluted by water.

· Do not spray disinfectant to プレーオフ nba device.

· Do not allow any liquid, such as disinfectant, to enter プレーオフ nba fiber socket.

Suggested retail price (excluding tax)^*2

JPY 400,000

Manufactured プレーオフ nba distributed by

Neuroceuticals, Inc.

Marketed by

Otsuka Pharmaceutical Factory, Inc.

Comarketed by

Otsuka Pharmaceutical Co., Ltd.

Medical device classification

General medical device

Generic name

Gastroesophageal sterile tube and caプレーオフ nbater for temporary use

Class category

Class I

Medical device notification number

13B1X10190000015

Shape, structure プレーオフ nba principle

<Shape, structure

Raw materials (*) of プレーオフ nba part which come in contact with

blood プレーオフ nba body fluids.

Insertion site: plastics, coating agent

<Principle

This product connects to プレーオフ nba light source device and is inserted to プレーオフ nba body while it is inserted in プレーオフ nba nasogastric tube. プレーオフ nba tip of プレーオフ nba insertion site shines by プレーオフ nba light from プレーオフ nba light source device, which enables to check プレーオフ nba tip position visually from outside プレーオフ nba body.

Purpose of use or effect

Insert this product with プレーオフ nba nasogastric tube into esophagus and stomach temporarily. By connecting this product to プレーオフ nba light source device, プレーオフ nba tip position can be visually checked from outside プレーオフ nba body.

Directions for use

Same as プレーオフ nba directions for use of プレーオフ nba Tumguide LED Light Source.

Storage プレーオフ nba expiration date

<Storage

· Store away from water.

· Store away from direct sunlight, high temperature, プレーオフ nba high humidity.

· Storage temperature: -10℃ - 45 ℃

· Storage humidity: 0% - 95% (No condensation)

<Expiration date As stated on プレーオフ nba product (By self-certification)

Packaging

10 fibers per box

Suggested retail price (excluding tax)^*2

JPY 23,000

Manufactured プレーオフ nba distributed by

Neuroceuticals, Inc.

Marketed by

Otsuka Pharmaceutical Factory, Inc.

Comarketed by

Otsuka Pharmaceutical Co., Ltd.