SJM™

Primary DI
05414734500449
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
424
Catalog number
424
Device description
MEDICAL ADHESIVE
Published
2017-04-10
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
KRGProgrammer, pacemaker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRGProgrammer, PacemakerCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P880086077

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P880086077ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSABBOTT MEDICAL1989-08-21DXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734500449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734500449054147345004495414734500449

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead repair kitA collection of sterile tools and materials designed to repair the lead of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). Typical components include a screwdriver, wrench, screws, crimps, adhesives, sealants, and other items used to repair a pacemaker lead or to reconnect a pacemaker/defibrillator lead to a pacemaker/defibrillator generator. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
790268031
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067052742Epic™ESP300-23ESP300-232026-07-08
05415067052759Epic™EELT-23AEELT-23A2026-07-08
05415067052766Epic™EELT-31MEELT-31M2026-07-08
05415067052780Epic™EELT-27MEELT-27M2026-07-08
05415067052797Epic™ESP300-25ESP300-252026-07-08
05415067052803Epic™ESP300-19ESP300-192026-07-08
05415067052810Epic™EELT-19AEELT-19A2026-07-08
05415067052827Epic™EELT-29MEELT-29M2026-07-08
05415067052834Epic™EELT-27AEELT-27A2026-07-08
05415067052858Epic™EELT-25AEELT-25A2026-07-08
05415067052865Epic™EELT-21AEELT-21A2026-07-08
05415067052872Epic™EELT-33MEELT-33M2026-07-08
05415067052889Epic™ESP300-27ESP300-272026-07-08
05415067052896Epic™EELT-25MEELT-25M2026-07-08
05415067052902Epic™ESP300-21ESP300-212026-07-08
05415067052964Epic™ESP1000-AESP1000-A2026-07-08
05415067052971Epic™EELT-1000MEELT-1000M2026-07-08
05415067052988Epic™EELT-1000AEELT-1000A2026-07-08
05415067054197NAEELT-19A-SEELT-19A-S2026-07-08
05415067054203NAEELT-29A-SEELT-29A-S2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479001575M-50BIOTRONIK SE & Co. KGKRG2024-10-16
00763000842536NAMEDTRONIC, INC.KRG2023-11-11
20763000842530NAMEDTRONIC, INC.KRG2023-11-11
00763000181185NAMEDTRONIC, INC.KRG2023-01-30
04035479176112DataBridge NABIOTRONIK SE & Co. KGKRG2022-12-14
00763000059545Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-10-21
00763000059651Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-10-21
00763000059668Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-10-21
00643169720138Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720145Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720190Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720206Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720251Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720268Viva™ S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720312Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720329Viva™ S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169929319Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929371Viva™ S CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929388Viva™ S CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929395Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929296Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-05-14
00643169929302Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-05-14
00643169929326Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-05-14
00643169929401Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-05-14
05414734006880Identity™ST. JUDE MEDICAL, INC.KRG2017-02-06
05414734006774Verity™ST. JUDE MEDICAL, INC.KRG2017-02-03
05414734006811Verity™ST. JUDE MEDICAL, INC.KRG2017-02-03
05414734006835Verity™ST. JUDE MEDICAL, INC.KRG2017-02-03
05414734006842Verity™ST. JUDE MEDICAL, INC.KRG2017-02-03
05414734006866Integrity™ST. JUDE MEDICAL, INC.KRG2017-02-03