FDA.reportPublic FDA data

NA

Primary DI
00613994501011
Brand
NA
Company
MEDTRONIC, INC.
Model
5873C
Device description
SERVICE KIT 5873C INTL US
Published
2014-09-23
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
DTBpermanent pacemaker Electrode
DXYimplantable pacemaker Pulse-generator
NVZPulse generator, permanent, implantable
OSRPacemaker/icd/crt non-implanted components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3
DXYImplantable Pacemaker Pulse-GeneratorCardiovascular3
NVZPulse Generator, Permanent, ImplantableUnknown3
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890003162

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003162SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994501011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994501011006139945010116139945010110613994501011

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
Handling Environment Temperature0 Degrees Fahrenheit90 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
Lot or batch
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
04035479190538SW HMSC 3.66BIOTRONIK SE & Co. KGOSR2026-05-28
00643169720589Evera MRI™ S VR SureScan®MEDTRONIC, INC.NVZ2020-11-13
00643169552043MyCareLink™MEDTRONIC, INC.OSR2019-10-13
00643169552272MyCareLink™MEDTRONIC, INC.NVZ2019-08-11
00643169634589Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634602Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634640Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169725379MyCareLink™MEDTRONIC, INC.NVZ2017-11-16
00643169725386MyCareLink™MEDTRONIC, INC.OSR2017-11-16
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169708600Adapta™MEDTRONIC, INC.NVZ2017-10-20
00643169709041Adapta™MEDTRONIC, INC.NVZ2017-10-20
00643169720404Evera™ XT DRMEDTRONIC, INC.NVZ2017-09-15
00643169720497Evera MRI™ XT DR SureScan®MEDTRONIC, INC.NVZ2017-09-15
00643169720619Visia AF™ VRMEDTRONIC, INC.NVZ2017-09-15
00643169837713Evera MRI™ XT DR SureScan™MEDTRONIC, INC.NVZ2017-09-15
00643169837744Evera MRI™ S DR SureScan™MEDTRONIC, INC.NVZ2017-09-15
00643169837799Visa AF MRI™ VR SureScan™MEDTRONIC, INC.NVZ2017-09-15
00643169708709Adapta™ LMEDTRONIC, INC.NVZ2017-06-24
00643169708808Adapta™MEDTRONIC, INC.NVZ2017-06-24
00643169708815Adapta™MEDTRONIC, INC.NVZ2017-06-24
00643169708846Adapta™MEDTRONIC, INC.NVZ2017-06-24
00643169708860Adapta™MEDTRONIC, INC.NVZ2017-06-24
00643169708945Sensia™MEDTRONIC, INC.NVZ2017-06-24
00643169708983Versa™MEDTRONIC, INC.NVZ2017-06-24
00643169633735CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.DTB2017-06-02
00643169633759CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.DTB2017-06-02