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

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05415067041739CPS AIM™DS2N101-65DS2N101-652022-10-20
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Primary DI, Brand, Company table
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04035479176112DataBridge NABIOTRONIK SE & Co. KGKRG2022-12-14
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00643169720145Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-09-15
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00643169720312Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-09-15
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00643169929395Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929296Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-05-14
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00643169929326Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-05-14
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05414734006880Identity™ST. JUDE MEDICAL, INC.KRG2017-02-06
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