FDA.reportPublic FDA data

NA

Primary DI
00763000181130
Brand
NA
Company
MEDTRONIC, INC.
Model
5846VL
Device description
CABLE 5846VL ROHS GLB 5PK
Published
2024-08-30
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
LWPImplantable pulse generator, pacemaker (non-CRT)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P820003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P820003000VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATORMedtronic Cardiac Rhythm Disease Management1982-11-16LWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000181134PackageGS15In Commercial Distribution
00763000181130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300018113420763000181134
00763000181130007630001811307630001811300763000181130

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA 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. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length366Centimeter

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

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
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
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

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.LWP2025-06-25
05415067050045Neutrino™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWP2024-11-13
00763000181116NAMEDTRONIC, INC.LWP2024-08-30
20763000181110NAMEDTRONIC, INC.LWP2024-08-30
20763000181134NAMEDTRONIC, INC.LWP2024-08-30
05415067040404NAST. JUDE MEDICAL, INC.LWP2023-01-09
05415067031174Merlin™ST. JUDE MEDICAL, INC.LWP2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.LWP2022-08-29
00763000181208NAMEDTRONIC, INC.LWP2021-05-22
00763000181215NAMEDTRONIC, INC.LWP2021-05-14
00763000316709Azure™ XT SR MRI SureScan™MEDTRONIC, INC.LWP2021-02-25
00763000316693Azure™ S DR MRI SureScan™MEDTRONIC, INC.LWP2021-01-08
00763000316716Azure™ S SR MRI SureScan™MEDTRONIC, INC.LWP2021-01-08
00763000316846Azure™ XT DR MRI SureScan™MEDTRONIC, INC.LWP2021-01-08
00763000316723Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316730Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316747Adapta™ SMEDTRONIC, INC.LWP2020-11-28
00763000316761Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316778Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316785Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316792Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316808Attesta™ DR MRI SureScan™MEDTRONIC, INC.LWP2020-07-30