YI XIN Sterile Syringe For Single Use

Basic Information

• Brand Name: YI XIN Sterile Syringe For Single Use
• Primary DI: 06945060500050
• Version / Model: Two-piece 10mL
• Company Name: Jiang Xi Sanxin Medtec Co., Ltd.
• Labeler DUNS: 530079367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-25
• Public Version: 2
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: abde0428-33fc-4ba7-b38f-0ab3674b6419

Device Description

YI XIN Sterile Syringe For Single Use, with needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from the body.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63095	General-purpose syringe/needle	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16945060500057	GS1		100	In Commercial Distribution
Primary	06945060500050	GS1
Package	26945060500054	GS1		12	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K050999	000