Jiajian

Basic Information

• Brand Name: Jiajian
• Primary DI: 00810011252301
• Version / Model: 50*50mm
• Company Name: Wuxi Jiajian Medical Instrument Co.,Ltd.
• Labeler DUNS: 529966489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-02
• Public Version: 1
• Public Version Date: 2019-07-10
• Public Version Status: New
• Public Device Record Key: 9cbf8dad-58c4-4da0-b10a-e7c247fbbbd4

Device Description

Flexible and easy to fit electrode can be applied to every contour of the human body. You can use the electrodes many times because of its reliable long lasting gel. 2 Electrodes in sealed foil pouch.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61170	Electrical probe/electrode conductive pad	A small, non-sterile device designed to facilitate electrical conduction between an electrical stimulation probe or electrode and the skin. It is typically contoured to fit on a particular type of probe/electrode and is made of an absorbent material (e.g., felt) that may be soaked in a conduction fluid. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810011252301	GS1
Package	00810011252318	GS1		800	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K090198	000