FDA.reportPublic FDA data

IS4/DF4 Adapter

Primary DI
04035479150259
Brand
IS4/DF4 Adapter
Company
BIOTRONIK SE & Co. KG
Model
412302
Catalog number
412302
Published
2015-08-03
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
P980023071

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980023071PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMBiotronik, Inc.1998-10-27LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479150495PackageGS15In Commercial Distribution
04035479150259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479150495040354791504954035479150495
04035479150259040354791502594035479150259

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead repair kitA collection of sterile tools and materials designed to repair the lead of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). Typical components include a screwdriver, wrench, screws, crimps, adhesives, sealants, and other items used to repair a pacemaker lead or to reconnect a pacemaker/defibrillator lead to a pacemaker/defibrillator generator. This is a single-use device.

Storage And Handling#

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

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
04035479194192PatientApp 2.10.05319975319972026-07-16
04035479110048Reocor S3655283655282014-08-13
04035479110055Reocor D3655293655292014-08-13
04035479114336Reocor D Redeladapter3712623712622014-08-21
04035479114343Reocor S Redeladapter3712633712632014-08-21
04035479114510Renamic PGH3715883715882014-08-21
04035479114527Renamic PGH ICD3715893715892014-08-21
04035479115142Renamic3719603719602014-08-12
04035479126391Renamic PSA Module3866103866102014-08-15
04035479143848Home Monitoring Service Center3.274053312014-08-21
04035479144241Home Monitoring Service Center3.284055522014-09-19
04035479144791BS IS-13308343308342014-08-04
04035479144807DH3316683316682014-08-14
04035479144968S 45-K1135881135882014-08-14
04035479144975S 45-S1300111300112014-08-14
04035479145019S 53-K1072351072352014-08-14
04035479145026S 53-S1300131300132014-08-14
04035479145033S 58-K1188771188772014-08-21
04035479148836Home Monitoring Service Center3.304084082015-04-22
04035479148850Home Monitoring Service Center3.324084102015-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00763000643454OmniaSecure™ MRI SureScan™MEDTRONIC, INC.NVY2025-12-19
00763000643478OmniaSecure™ MRI SureScan™MEDTRONIC, INC.NVY2025-12-19
00763000643539OmniaSecure™ MRI SureScan™MEDTRONIC, INC.NVY2025-12-19
00763000180010Sprint Quattro Secure S™MEDTRONIC, INC.NVY2024-11-04
00763000180027Sprint 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