FDA.reportPublic FDA data

NA

Primary DI
00763000181215
Brand
NA
Company
MEDTRONIC, INC.
Model
5103
Device description
ADAPTOR CABLE 5103
Published
2021-05-14
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
DXYimplantable pacemaker Pulse-generator
LWPImplantable pulse generator, pacemaker (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXYImplantable Pacemaker Pulse-GeneratorCardiovascular3
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890003437

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003437SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000181215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000181215007630001812157630001812150763000181215

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067055507Zenex MRI™ST. JUDE MEDICAL, INC.LWP2026-01-22
05415067055514Zenex MRI™ST. JUDE MEDICAL, INC.LWP2026-01-22
05415067049575Merlin™ST. JUDE MEDICAL, INC.DXY2025-06-25
05415067049575Merlin™ST. JUDE MEDICAL, INC.LWP2025-06-25
00763000812058NAMEDTRONIC, INC.DXY2025-04-12
05415067050045Neutrino™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050045Neutrino™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.DXY2024-11-13
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWP2024-11-13
00763000181116NAMEDTRONIC, INC.LWP2024-08-30
00763000181130NAMEDTRONIC, INC.LWP2024-08-30
20763000181110NAMEDTRONIC, INC.LWP2024-08-30
20763000181134NAMEDTRONIC, INC.LWP2024-08-30
08031527018997BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019000BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019017BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019024BlueSkyMICROPORT CRM SRLDXY2023-06-23
05415067040404NAST. JUDE MEDICAL, INC.LWP2023-01-09
05415067040404NAST. JUDE MEDICAL, INC.DXY2023-01-09
05415067031174Merlin™ST. JUDE MEDICAL, INC.LWP2022-08-29