FDA.reportPublic FDA data

Medtronic CareLink® Programmer

Primary DI
00613994581570
Brand
Medtronic CareLink® Programmer
Company
MEDTRONIC, INC.
Model
2090
Device description
PRGM 2090 USA EN OS MIGRATION EXTENSION
Published
2014-09-23
Public version status
Update
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
OSRPacemaker/icd/crt non-implanted components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRGProgrammer, PacemakerCardiovascular3
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890003151

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003151SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994581570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994581570006139945815706139945815700613994581570

GMDN Terms#

Term, Definition table
TermDefinition
Pacemaker programmerAn external device that enables a user to interrogate, test, analyse and program, noninvasively, one or more of the operating parameters (the programs) of an implanted cardiac pacemaker. It is able to read stored parameters in the pacemaker, providing historic and/or current information regarding performance, and may be used to upload new software into the pacemaker. It is a dedicated device, typically with an electronic wand with a communication antenna, connected to a port of a personal computer (PC) using dedicated software to drive the electronics of the wand to communicate with the implanted pacemaker.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-7.6 Degrees Fahrenheit140 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
04035479190538SW HMSC 3.66BIOTRONIK SE & Co. KGOSR2026-05-28
00802526628900LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2026-05-14
00802526627903LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2026-01-21
04035479189235SW HMSC 3.65BIOTRONIK SE & Co. KGOSR2026-01-20
04035479189044SW HMSC 3.64BIOTRONIK SE & Co. KGOSR2025-10-16
00802526625206LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2025-06-26
05415067049575Merlin™ST. JUDE MEDICAL, INC.OSR2025-06-25
04035479188689SW HMSC 3.63BIOTRONIK SE & Co. KGOSR2025-05-07
00763000812058NAMEDTRONIC, INC.OSR2025-04-12
04035479187927SW HMSC 3.62BIOTRONIK SE & Co. KGOSR2025-01-20
04035479188399NEO 2401.U/1BIOTRONIK SE & Co. KGOSR2024-12-18
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.OSR2024-11-13
04035479001575M-50BIOTRONIK SE & Co. KGKRG2024-10-16
04035479176143Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-09-20
04035479187163Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-09-03
04035479186005NEOBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186012PSWBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186128Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-05-29
00763000378356Instrument Command LibraryMEDTRONIC, INC.OSR2024-05-04
00763000378363Device Command LibraryMEDTRONIC, INC.OSR2024-05-04
04035479184636Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-01-10
04035479184285NEOBIOTRONIK SE & Co. KGOSR2023-12-15
04035479184292PSWBIOTRONIK SE & Co. KGOSR2023-12-15
04035479185510Renamic Neo NEOexpressBIOTRONIK SE & Co. KGOSR2023-12-15
00763000842536NAMEDTRONIC, INC.OSR2023-11-11
00763000842536NAMEDTRONIC, INC.KRG2023-11-11
20763000842530NAMEDTRONIC, INC.KRG2023-11-11
00802526622601LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2023-10-27
00802526622908LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2023-10-27
04035479183264Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2023-10-13