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product detail

Device Name

Specification

Length ×Width

Basic UDI-DI

Device figure

Medical mask

17.5cm×9.5cm, 

17.5cm×9.5cm,

14.5cm×9.5cm,

14.5cm×9.0cm

697313440MGMM001L3

Definitions of Signs03

Medical mask

17.5cm×9.5cm, 

17.5cm×9.5cm,

14.5cm×9.5cm,

697313440MGMM002L5

Definitions of Signs03

[Caution]

1)This product is for single use only, please do not reuse it.

2)Please check the integrity of the package before use, ifthe package is damaged, please do not use it.

3)Please read the instructions carefully before use. If theproduct has expired, please do not use it.

4)Please inform the manufacturer and competent authority in case of any adverse events related to theequipment failure.

[Use Method]

1)Wash hands

2)Take out the mask and face the white side of the mask to yourself,Put the side with the bridge of the nose upward

3)Put the ear bands on both sides of the mask over both ears

4)Adjust the bridge of nose to make it close to the bridge of nose.

[Storage conditions]

The product shall be stored in a dry, ventilated, non-corrosive environment and kept away from fire and flammable materials.

[Shelf-life]

3 years.

[Sterility]

EO sterilization

[Intended User]

Medical professionals in a specialty, clinical nurses

[Intended Patient Populations]

Patients who need to block external microorganisms from passing through respiratory tract infection, which including all age groups.

Age: no restrictions

Weight: no restrictions

Gender: no restrictions

Nationality: multiple

[Intended using environment]

Hospitals, health centers, clinics.

[Side effect ]

Skin allergy, redness and swelling at the contact part, dyspnea

[Medical Conditions]

Need to block the spread of germs

[Indications]

Patients with exudate from wound.

[Contraindications ]

It is forbidden for people who are allergic to non-woven fabrics

product detail

NO.

Name

Intended Use

1

Sterile Field

Used to package medical devices

2

Drape

Used to provide a physical barrier to protect the surgical area from contamination

3

Gauze Ball without X-ray

Gauze Ball without X-ray is used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates. It is only intended to be used as a mechanical barrier; and not contact mucous membrane or manage the micro-environment of injured skin.

4

Non-woven gauze ball

Used for wound and wound cleaning and care

5

Cotton Ball

Used for cleaning skin and wounds.

6

Non-woven gauze pads

Used for surgical or local wound care by medical staff

7

Gauze Sponge without X-ray

Gauze Sponge without X-ray is used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates. It is only intended to be used as a mechanical barrier; and not contact mucous membrane or manage the micro-environment of injured skin.

8

Hand Towel

Used for wiping hands

9

Absorbent Pad

used to absorb a large amount of exudate and keep the wound and skin surface dry. It is only intended to be used as a mechanical barrier; and not contact mucous membrane or manage the micro-environment of injured skin. It contains CELLULOSE

10

Purcotton swabs

used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates. It is only intended to be used as a mechanical barrier; and not contact mucous membrane or manage the micro-environment of injured skin.

11

Medical Mask

Sterile Medical mask used for clinical medical personnel wearing during invasive procedures, and providing protection for receiving treatment patients and implementation of invasive operations medical personnel to stop the blood, body fluids and spatter spreading.

12

Disposable Examination Gloves

Used by medical staff to prevent cross infection between patients and users or to handle contaminated medical materials during the examination, diagnosis, and treatment process.

13

Plastic forceps

Used for gripping items during the diagnosis and treatment process

14

Disposable scissors

used to cut dressings

15

Plastic Trays

Used for storing, classifying, and transporting various medical equipment

16

PE apron

Used for effective isolation of pollutants, reducing the chances and risks of infection, and ensuring hygiene in the medical process

17

Plastic cup

Used for temporary storage of iodine or alcohol

18

Biohazard Bag

Used for storing and transporting medical specimens

product detail

Signs Description Signs Description Signs Description
 Definitions of Signs01 Trademark of Manufacturer  Definitions of Signs08 Batch number  Definitions of Signs021 Date of Manufacture
 Definitions of Signs02 Medical device  Definitions of Signs010 Model number  Definitions of Signs020 Country of manufacturer
 Definitions of Signs03 Use-by date  Sterilized using ethylene oxide Sterilized using ethylene oxide  Definitions of Signs019 Caution
 Definitions of Signs04 Non-pyrogenic  Definitions of Signs012 Catalogue number  Definitions of Signs018 Unique Device Identifier
 Single sterile barrier system Single sterile barrier system  Double sterile barrier system Double sterile barrier system  Definitions of Signs017 Keep away from sunlight
 Definitions of Signs06 Do not reuse  Definitions of Signs014 Do not use if the package is damaged  Definitions of Signs016 Keep dry
 Do not resterilize Do not resterilize  Definitions of Signs09 Authorized representative in the European Community  Definitions of Signs015 Manufacturer
 Definitions of Signs07 CE marking of conformity, and Notified Body Code  Definitions of Signs09 Consult instructions for use / /

Manufacturer

Name: Haian Medigauze Co.,Ltd.

Address: Jiaoxie Industry park,226633Haian, Jiangsu,PEOPLE'S REPUBLIC OF CHINA

Tel: +86-513-88240958

Web: www.medigauze.com

  • mail: produce@medigauze.com

SRN:CN-MF-000009960

European Authorized Representative

Name:Shanghai International Holding Corp. GmbH (Europe)

Add:Eiffestrasse 80, 20537 Hamburg, Germany

E-mail:shholding@hotmail.com

SRN: DE-AR-000000001