FDA.reportPublic FDA data

JENITEK

Primary DI
06973102450018
Brand
JENITEK
Company
SUZHOU JENITEK MEDICAL CO.,LTD.
Model
Pacemaker test magnet 50311000
Published
2020-07-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DTGMagnet, Test, Pacemaker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTGMagnet, Test, PacemakerCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973102450015PackageGS120In Commercial Distribution
06973102450018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697310245001516973102450015
06973102450018069731024500186973102450018

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator test magnetA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542975488
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973102450506Jenitek Torque WrenchSJ-TW-1002025-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05414734507004NAST. JUDE MEDICAL, INC.DTG2025-04-30
08031527019956MagnetMICROPORT CRM SRLDTG2021-09-23
05425025750313VITARIA™ Patient Essentials, Model 7220LIVANOVA USA, INC.DTG2020-06-29
20613994647812NAMEDTRONIC, INC.DTG2014-10-27
05425025750252Cyberonics® Patient MagnetLIVANOVA USA, INC.DTG2014-09-17