Sterilized three parts two parts disposable injection syringes with needles

Description of disposable syringes

1)Components:The products is assembled with coat and core staff (or with piston), and match syringe needle in uses; needles are assembled with needle tube, needle stand and protective coat；

2)Production environment: 100000 class cleanliness area

3) antipollution measure: Cleaning workshop

User’s manual and precautions

1 Intended use:

Sterile Syringe for Single Use: Assembly and provide sterile syringe for single use for clinical human body hypodermic injection and solution aspiration.

2 This products should be operated by qualified professional medical physician, Before using, if the individual packing is damaged, it can’t be used; Pick up the syringe from the packing, should not be contaminated, match the needle with the syringe together, make sure it tight.

3. Use for only one time, destroy it after one time using; should be used before valid time.

Commercial presentation:

1ml, 1pc/pe bag,100pcs/box,36box/carton

3ml, 1pc/pe bag,100pcs/box,30box/carton

5ml, 1pc/pe bag,100pcs/box,24box/carton

10ml,pc/pe bag,100pcs/box,16box/carton

20ml, 1pc/pe bag,50pcs/box,18box/carton

50ml/60ml, 1pc/pe bag,20pcs/box,18box/carton

Probable harm in the design, produce and deliver.

1)What is the intended use /intended purpose and how is the medical device to be used?

Intended use:

Sterile syringe for single use: Assembly sterile syringe for single use to used in clinical human body hydrodermic injection and body solution aspiration.

Intended purpose: use as medical appliance.

How is the medical device to be used: used by professional person.

2)Is the medical device intended to contact the patient or other persons?

Will contact the patient short-term in use.

3)What materials and / or components are incorporated in the medical device or are used with, or are in contact with, the medical device?

Main raw materials: medical level PP, PC, stainless tube.Pump liquid medicine by this products in use.

4)Is energy delivered to and /or extracted from the patient?

No energy.

5)Are substances delivered to and /or extracted from the patient?

It is only used as an implement to pump the liquid medicine and then inject them to the patient.

6)Are biological materials processed by the medical device for subsequent re-use?

It is only for single use, don not re-use again.

7)Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?

It is supplied as axenic products.

8)Is the medical device intended to be routinely cleaned and disinfected by the user?

No.

9)Is the medical device intended to modify the patient environment?

It does not modify the patient environment.

10)Are measurements taken?

It needs measurement.

11)Is the medical device interpretative?

It is not interpretative.

12)Is the medical device intended for use in conjunction with medicines or other medical technologies?

It is in conjunction with medicines or other medical technologies.

13)Are there unwanted outputs of energy or substances?

It is sterilized by EO gas and there are unwanted outputs of energy and substances.

14)Is the medical device susceptible to environmental influences?

It is not susceptible to environmental influences.

15)Does the medical device influence the environment?

It is for once time use and has special disposal.

16)Are there essential consumables or accessories associated with the medical device?

There are no any essential consumables or accessories associated.

17)Is maintenance and /or calibration necessary?

It is no need to maintain by professional person.

18)Does the medical device contain software?

No software contained in the product.

19)Does the medical device have a restricted shelf-life?

It has storage life, the storage life is 5 years from the sterilization date if observe the storage rule.

20)Are there any delayed and /or long-term use effects?

It is only for single use.

21)To what mechanical forces will the medical device be subjected?

It can subject necessary mechanical forces in use.

22)What determines the lifetime of the medical device?

Sterilization validity date determine the shelf-life.

23)Is the medical device intended for single use?

It is for single use.

24)Is safe decommissioning or disposal of the medical device necessary?

Safe decommissioning and disposal of it is necessary for defending re-use.

25)Does installation or use of the medical device require special training?

It is used by professional person.

26)Will new manufacturing processes need to be established or introduced?

No need for the moment.

27)Is successful application of the medical device critically dependent on human factors such as the user interface?

The successful application is ling on man factor absolutely.

28)Is the medical device intended to be mobile or portable?

It is intended to be mobile or portable.