JENITEK

Basic Information

• Brand Name: JENITEK
• Primary DI: 06973102450018
• Version / Model: Pacemaker test magnet 50311000
• Company Name: SUZHOU JENITEK MEDICAL CO.,LTD.
• Labeler DUNS: 542975488
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-06
• Public Version: 4
• Public Version Date: 2021-02-02
• Public Version Status: Update
• Public Device Record Key: e661a362-451b-4b6c-b85d-0dd315dd72a9

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DTG	Magnet, Test, Pacemaker	Cardiovascular	870.3690	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31704	Cardiac pulse generator test magnet	A magnetized device used to test an inhibited or triggered type of pacemaker or defibrillator, and cause an inhibited or triggered generator to revert to asynchronous operation. The device is placed on the outside of the patient's thorax over the pacemaker/defibrillator for analysis of the implanted device's function. The magnet will activate the magnet sensitive relay in the pacemaker/defibrillator and will change the function of the implanted device. It is possible to evaluate the function of the implanted device via an electrocardiograph.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06973102450018	GS1
Package	16973102450015	GS1	Outer package	20	In Commercial Distribution