Syringes Micsafe

Description

This is the specs of the syringes we can offer. The 510k is being renewed and we will have an updated one once buyers engage.

Payment by LC to Sinopharm. The current price is 20c per syringe which is very good.
The demand is thru the roof and there is a waiting period of at least 8-9 months with most suppliers.

Trade/Device Name: Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile
Syringe with Needle, Hypodermic Needle for Single Use

Regulation Number: 21 CFR 880.5860
Regulation Name: Piston Syringe
Regulatory Class: Class II
Product Code: MEG, FMF, FMI

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known)
K183665
Device Name
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
Indications for Use (Describe)
Safety Needles
The safety needles are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for
medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually
activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Sterile Syringe
The sterile syringe is a sterile luer lock or luer slip syringe which is intended to be used with a hypodermic needle for the
aspiration and injection of fluids for medical purpose.
Sterile Syringe with Safety Needle
The sterile syringe with safety needle is intended for use in the aspiration and injection of fluids for medical purpose.
After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the
needle immediately after use to minimize risk of accidental needle sticks.
Sterile Syringe with Needle
The sterile syringe with needle is intended for use the aspiration and injection of fluids for medical purpose.
Hypodermic Needles for Single Use
The hypodermic needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for
medical purpose.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

Common Name(s):Syringe, Antistick
Syringe, Piston
Needle, Hypodermic, Single Lumen
Type of use: Prescription use only
Predicate Device: Sterile Disposable Syringe With Safety Needle, Sterile Disposable Syringe
With Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable
Needle (K170651)

Device Description

(1)Safety Needles
The Safety Needles are intended for manual and single use only. They consist of a needle cap,
needle tube and hub with protector. The proposed device is compatible for use with a luer slip or
luer lock syringe. The safety sheath will be manually activated to cover the needle immediately
after use to minimize risk of accidental needle sticks.

(2)Sterile Syringe
The Sterile Syringe is intended for manual and single use only. It consists of a Barrel, Plunger,
and Piston. The syringes are available with luer slip and luer lock connector types and are
available in different sizes. They are intended to be connected to a safety/hypodermic needle.
(3)Sterile Syringe with Safety Needle
This product is intended for manual and single use only. The Sterile Syringe with Safety Needle
consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or
luer lock syringe. The proposed device is available in a variety of syringe and needle sizes. The
safety sheath will be manually activated to cover the needle immediately after use to minimize
risk of accidental needle sticks.
(4)Sterile Syringe with Needle
The Sterile Syringe with Needle is intended for manual and single use only. It consists of a
hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a
variety of syringe and needle sizes.
(5)Hypodermic Needles for Single Use
The Hypodermic Needle is intended for manual and single use only. It consists of a hub, needle
tube, needle cap. The proposed device is compatible for use with a luer slip or luer lock syringe.
Configurations and Sizes
(1)Safety Needles
18G; 20G; 21G; 22G; 23G; 25G; 26G
(2)Sterile Syringe
Luer Slip 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
Luer Slip Eccentric 20ml, 30ml, 50ml
Luer Lock 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
(3)Sterile Syringe with Safety Needle
Luer Slip 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
Luer Slip Eccentric 20ml, 30ml, 50ml
Luer Lock 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
Needle Size:18G; 20G; 21G; 22G; 23G; 25G; 26G
(4)Sterile Syringe with Needle
Luer Slip 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
Luer Slip Eccentric 20ml, 30ml, 50ml
Luer Lock 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
Needle Size:18G ; 19G; 20G; 21G; 22G; 23G; 24G; 25G; 26G; 27G; 28G;
29G; 30G; 31G
MICSAFE MEDICAL GROUP
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(5)Hypodermic Needles for Single Use
18G; 19G; 20G; 21G; 22G; 23G; 24G; 25G; 26G; 27G; 28G; 29G; 30G;
31G