FDA.reportPublic FDA data

NA

Primary DI
00643169431850
Brand
NA
Company
MEDTRONIC, INC.
Model
5437
Device description
CABLE 5437 ROHS GLB 10L
Published
2015-07-01
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890003065

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003065SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169431850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169431850006431694318506431694318500643169431850

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
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit158 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
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19
00199150084067MiniMed Extended Supply KitMMT-445C2026-07-19
00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13

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