FDA.reportPublic FDA data

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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRGProgrammer, pacemaker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRGProgrammer, PacemakerCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950037000
P950037089

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950037000DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSBiotronik, Inc.1996-10-11DXY
P950037089DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSBiotronik, Inc.1996-10-11DXY

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 Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315620229
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479170295Tunneler L4578564578562026-05-28
04035479190538SW HMSC 3.664980924980922026-05-28
04035479182755Rivacor Sky DR-T4819824819822026-04-20
04035479182779Rivacor Sky VR-T DX4819834819832026-04-20
04035479182793Rivacor Sky VR-T4819844819842026-04-20
04035479182809Acticor Sky HF-T QP4819854819852026-04-20
04035479182816Acticor Sky HF-T4819864819862026-04-20
04035479182823Acticor Sky DR-T4819874819872026-04-20
04035479182830Acticor Sky VR-T DX4819884819882026-04-20
04035479182847Acticor Sky VR-T4819894819892026-04-20
04035479182854Rivacor Sky HF-T QP4819904819902026-04-20
04035479182861Rivacor Sky HF-T4819914819912026-04-20
04035479182984Rivacor Aura HF-T QP4820124820122026-04-20
04035479182991Rivacor Aura HF-T4820134820132026-04-20
04035479183004Rivacor Aura DR-T4820144820142026-04-20
04035479183011Rivacor Aura VR-T4820154820152026-04-20
04035479183028Rivacor Rise HF-T QP7820164820162026-04-20
04035479183035Rivacor Rise HF-T4820174820172026-04-20
04035479183042Rivacor Rise DR-T4820184820182026-04-20
04035479183059Rivacor Rise VR-T DX4820194820192026-04-20

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