CAINA

Basic Information

• Brand Name: CAINA
• Primary DI: 06971564465380
• Version / Model: 1ML LL 25GX1
• Catalog Number: SNL12510
• Company Name: Jiangsu Caina Medical Co.,Ltd
• Labeler DUNS: 544543513
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-10
• Public Version: 1
• Public Version Date: 2021-04-19
• Public Version Status: New
• Public Device Record Key: 63b3d6a1-4d2c-4915-86f4-536751e81402

Device Description

1 ml luer lock syringe with needle 25Gx1.The syringes are intended to inject fluids into or withdraw fluids 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: Yes
• 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: No
• 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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2
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	16971564465387	GS1		100	In Commercial Distribution
Primary	06971564465380	GS1
Package	26971564465384	GS1		12	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K113091	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Milliliter
Needle Gauge	25	Gauge
Length	1	Inch