FDA.reportPublic FDA data

NA

Primary DI
00613994220288
Brand
NA
Company
MEDTRONIC, INC.
Model
5019
Device description
SPLITTER KIT 5019 M-4 HV GLBL 17-L CE MK
Published
2015-06-10
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
LWSImplantable cardioverter defibrillator (non-CRT)
NVYPermanent defibrillator electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3
NVYPermanent Defibrillator ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P920015093

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920015093MEDTRONIC(R) TRANSVENE LEAD SYSTEMMedtronic, Inc.1993-12-09NVY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994220288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994220288006139942202886139942202880613994220288

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead electrical extension adaptorAn implantable sterile device used to provide a functional and modified connection between existing pacing leads (e.g., IS-1 leads) and an implantable pacing/defibrillation device (e.g., pacemaker, defibrillator). It typically consists of a small connector block to enable attachment to the pacing leads (i.e., when they do not meet connection design) and extension leads to increase the reach of the pacing leads. During implantation the surgeon uses a tool to tighten the connections (e.g., a Hex wrench), and a medical adhesive to seal the connections from body fluid contamination. This device facilitates the implantation of the pacing device and/or is useful if two leads need to be implanted.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169988651Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2017-09-25
00643169720374Evera™ XT DRMEDTRONIC, INC.LWS2017-09-15
00643169720527Evera MRI™ S DR SureScan®MEDTRONIC, INC.LWS2017-09-15
00643169720558Evera MRI™ XT VR SureScan®MEDTRONIC, INC.LWS2017-09-15
00643169720626Visia AF™ VRMEDTRONIC, INC.LWS2017-09-15
00643169720794Visia AF MRI™ VR SureScan™MEDTRONIC, INC.LWS2017-09-15
00643169837829Visa AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2017-09-15
00643169858305Sprint Quattro™ MRI SureScan™MEDTRONIC, INC.LWS2017-06-11
00643169858329Sprint Quattro™ MRI SureScan™MEDTRONIC, INC.NVY2017-06-11
00643169453180CapSureFix™ NovusMEDTRONIC, INC.NVY2017-06-02
00643169633735CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633742CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633766CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633773CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633780CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169929258Evera MRI™ S DR SureScan™MEDTRONIC, INC.LWS2017-05-22
00643169929265Evera MRI™ S DR SureScan®MEDTRONIC, INC.LWS2017-05-22
00643169929944Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2017-05-22
00643169857674SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2017-05-21
00643169857681SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2017-05-21
00643169857698SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2017-05-21
00643169929197Evera MRI™ XT DR SureScan™MEDTRONIC, INC.LWS2017-05-14
00643169929760Visia AF™ VRMEDTRONIC, INC.LWS2017-05-14
00643169929913Visia AF MRI™ VR SureScan™MEDTRONIC, INC.LWS2017-05-12
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448858CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169708174CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVY2016-12-26