M-50

Primary DI
04035479001575
Brand
M-50
Company
BIOTRONIK SE & Co. KG
Model
112149
Catalog number
112149
Published
2024-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRGProgrammer, pacemaker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRGProgrammer, PacemakerCardiovascular3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479001575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479001575040354790015754035479001575

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags#

DUNS number
315620229
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479189235SW HMSC 3.654966314966312026-01-20
04035479162054Selectra 3D-40-324436244436242020-11-12
04035479162061Selectra 3D-40-394436254436252020-11-12
04035479162078Selectra 3D-55-324436264436262020-11-12
04035479162085Selectra 3D-55-394436274436272020-11-12
04035479162092Selectra 3D-65-324436284436282020-11-12
04035479162108Selectra 3D-65-394436294436292020-11-12
07640130455399Selectra3D-40-424517892020-11-12
07640130455405Selectra3D-55-424517902020-11-12
07640130455412Selectra3D-65-424517912020-11-12
04035479176228Selectra 3D-65-424517914517912021-06-02
04035479176235Selectra 3D-55-424517904517902021-06-02
04035479176242Selectra 3D-40-424517894517892021-06-02
04035479116828SelectraIC-50-653755452014-08-27
04035479116835SelectraIC-50-753755462014-08-27
04035479116842SelectraIC-90-653755472014-08-27
04035479116859SelectraIC-90-753755482014-08-27
04035479116651Selectra Amplatz 6.0-453755193755192014-08-27
04035479116668Selectra Amplatz 6.0-553755203755202014-08-27
04035479116675Selectra BIO2-453755233755232014-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000842536NAMEDTRONIC, INC.KRG2023-11-11
20763000842530NAMEDTRONIC, INC.KRG2023-11-11
00763000181185NAMEDTRONIC, INC.KRG2023-01-30
04035479176112DataBridge NABIOTRONIK SE & Co. KGKRG2022-12-14
00763000059545Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-10-21
00763000059651Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-10-21
00763000059668Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-10-21
00643169720138Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720145Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720190Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720206Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720251Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720268Viva™ S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720312Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720329Viva™ S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169929319Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929371Viva™ S CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929388Viva™ S CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929395Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929296Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-05-14
00643169929302Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-05-14
00643169929326Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-05-14
00643169929401Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-05-14
05414734500449SJM™ST. JUDE MEDICAL, INC.KRG2017-04-10
05414734006880Identity™ST. JUDE MEDICAL, INC.KRG2017-02-06
05414734006774Verity™ST. JUDE MEDICAL, INC.KRG2017-02-03
05414734006811Verity™ST. JUDE MEDICAL, INC.KRG2017-02-03
05414734006835Verity™ST. JUDE MEDICAL, INC.KRG2017-02-03
05414734006842Verity™ST. JUDE MEDICAL, INC.KRG2017-02-03
05414734006866Integrity™ST. JUDE MEDICAL, INC.KRG2017-02-03