FDA.reportPublic FDA data

BK-IS4/DF4

Primary DI
04035479132613
Brand
BK-IS4/DF4
Company
BIOTRONIK SE & Co. KG
Model
395399
Catalog number
395399
Published
2014-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVYPermanent defibrillator electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVYPermanent Defibrillator ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980023057

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980023057PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMBiotronik, Inc.1998-10-27LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479132613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479132613040354791326134035479132613

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead capAn implantable device designed to cover and protect the lead terminals of an implantable pacing device (e.g., an implanted pacemaker or defibrillator) during the implantation procedure, or to isolate (cap) any lead terminals that are not used. This device is implanted with the pacemaker or defibrillator system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit131 Degrees Fahrenheit

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479190705NEO 2601.U4991024991022026-09-21
04035479190712PSW 2601.U4991034991032026-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000643430OmniaSecure™ MRI SureScan™MEDTRONIC, INC.NVY2025-12-19
00763000643454OmniaSecure™ MRI SureScan™MEDTRONIC, INC.NVY2025-12-19
00763000643478OmniaSecure™ MRI SureScan™MEDTRONIC, INC.NVY2025-12-19
00763000180010Sprint Quattro Secure S™MEDTRONIC, INC.NVY2024-11-04
00763000180034Sprint Quattro Secure S™MEDTRONIC, INC.NVY2024-11-04
00763000180041Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180058Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180119Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180232Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000180256Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180263Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180317Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180324Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180331Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000180348Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000369743Epsila EV™MEDTRONIC, INC.NVY2023-11-03
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00763000369767Epsila EV™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00763000571528NAMEDTRONIC, INC.NVY2023-07-30
00763000740269SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2022-12-11
00763000059385NAMEDTRONIC, INC.NVY2018-12-22
00763000130800SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2018-10-11
00763000130817SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2018-10-11
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00763000014643CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-20
00763000014667CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-20
00763000014704CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-20
00763000014711CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-20