BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 05414734507004 · Model: 3111 · ST. JUDE MEDICAL, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: NA
Primary DI: 05414734507004
Version / Model: 3111
Catalog Number: 3111
Company Name: ST. JUDE MEDICAL, INC.
Labeler DUNS: 790268031
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-04-30
Public Version: 1
Public Version Date: 2025-05-08
Public Version Status: New
Public Device Record Key: 38cf2f3a-ebdd-4c49-bbfe-c85ad27fa446

Device Description

Ferrite Magnet

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: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: No
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	05414734507004	GS1

Customer Contacts

Phone: +1(855)478-5833
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3.0000	Inch

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: -4 – 140 Degrees Fahrenheit
Type: Storage Environment Temperature
Temperature Range: -4 – 140 Degrees Fahrenheit
Type: Storage Environment Temperature
Temperature Range: -20 – 60 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Handling Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: -20 – 60 Degrees Celsius