FDA.reportPublic FDA data

Supreme™

Primary DI
05414734206686
Brand
Supreme™
Company
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Model
401981
Catalog number
401981
Device description
Electrophysiology Extension CableBLUE
Published
2015-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCABLE, ELECTRODE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734206686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734206686054147342066865414734206686

GMDN Terms#

Term, Definition table
TermDefinition
Electrical catheter connection cable, reusableAn insulated electrical conductor designed to provide an electrical connection between an electrical catheter (e.g., an electrophysiological diagnostic catheter or ablation catheter) and an electrically-powered parent device (e.g., generator, analyser). Its length may also allow the catheter to remain in the sterile field. This device will be made of robust materials with metal connectors, e.g., gold (Au) plated electrical connecting pins and sockets, that ensure continued reliability each time it is reused. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.5Meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL,DARK,DRY PLACE. Protect from radioactive sources.
Special Storage Condition, Specify00STORE IN A COOL,DARK,DRY PLACE. Protect from radioactive sources.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
040960379
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067002853Angio-Seal™VIP6101312014-10-24
05414734054591Angio-Seal™VIP6101302014-10-24
05415067002839Angio-Seal™Evolution™C6101342014-10-24
05415067002846Angio-Seal™Evolution™C6101352014-10-24
05415067002860Angio-Seal™STS Plus6101192014-10-24
05415067002877Angio-Seal™STS Plus6101212014-10-24
05414734202701Livewire™4019424019422023-10-31
05414734202176Livewire™4015724015722015-03-05
05414734202312Livewire™4016004016002015-03-05
05414734202329Livewire™4016034016032015-03-05
05414734202336Livewire™4016064016062015-03-05
05414734202350Livewire™4016484016482015-03-05
05414734202411Livewire™4016544016542015-03-05
05414734202596Livewire™4019184019182015-03-05
05414734202633Livewire™4019334019332015-03-05
05414734202640Livewire™4019344019342015-03-05
05414734202657Livewire™4019354019352015-03-05
05414734202763Livewire™4020224020222015-03-05
05414734202398Livewire™4016524016522015-02-06
05414734001052Pacel™4017664017662015-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725502341APKAPK Technology Co.,Ltd.IKD2026-10-22
06946725500989APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500996APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501009APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501016APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501030APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501047APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501054APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501061APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501078APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501085APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501092APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501108APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501115APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501122APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501139APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501146APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501153APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501160APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501177APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501184APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501191APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501207APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501214APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501221APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501238APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501245APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501252APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501269APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501276APKAPK Technology Co.,Ltd.IKD2025-07-22