FDA.reportPublic FDA data

REMOTE ASSISTANT™

Primary DI
00681490199285
Brand
REMOTE ASSISTANT™
Company
MEDTRONIC, INC.
Model
9462
Device description
SFTWR 9462 ACTVTR PATIENT REMOTE ASST
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXYimplantable pacemaker Pulse-generator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXYImplantable Pacemaker Pulse-GeneratorCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970012000MEDTRONIC.KAPPA 400 SERIES PACEMAKERSMedtronic, Inc.1998-01-30NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00681490199285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681490199285006814901992856814901992850681490199285

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator test magnetA magnetized device used to test an inhibited or triggered type of pacemaker or defibrillator, and cause an inhibited or triggered generator to revert to asynchronous operation. The device is placed on the outside of the patient's thorax over the pacemaker/defibrillator for analysis of the implanted device's function. The magnet will activate the magnet sensitive relay in the pacemaker/defibrillator and will change the function of the implanted device. It is possible to evaluate the function of the implanted device via an electrocardiograph.

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
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067049575Merlin™ST. JUDE MEDICAL, INC.DXY2025-06-25
00763000812058NAMEDTRONIC, INC.DXY2025-04-12
05415067050045Neutrino™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.DXY2024-11-13
08031527018997BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019000BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019017BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019024BlueSkyMICROPORT CRM SRLDXY2023-06-23
05415067040404NAST. JUDE MEDICAL, INC.DXY2023-01-09
05415067031174Merlin™ST. JUDE MEDICAL, INC.DXY2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.DXY2022-08-29
00763000181215NAMEDTRONIC, INC.DXY2021-05-14
00763000307660NAMEDTRONIC, INC.DXY2020-07-05
00763000059477NAMEDTRONIC, INC.DXY2018-12-28
05414734006880Identity™ST. JUDE MEDICAL, INC.DXY2017-02-06
05414734006811Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006835Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006842Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006866Integrity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006910Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734009553Victory™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734010474Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006828Identity™ST. JUDE MEDICAL, INC.DXY2017-01-25
05414734006903Identity™ST. JUDE MEDICAL, INC.DXY2017-01-25
00643169838604NAMEDTRONIC, INC.DXY2016-10-08