FDA.reportPublic FDA data

NA

Primary DI
20763000181110
Brand
NA
Company
MEDTRONIC, INC.
Model
5846AL
Device description
CABLE 5846AL ROHS GLB 5PK
Published
2024-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20763000181110PackageGS15In Commercial Distribution
00763000181116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300018111020763000181110
00763000181116007630001811167630001811160763000181116

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

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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.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
00763000181130NAMEDTRONIC, 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