FDA.reportPublic FDA data

Livewire™

Primary DI
05414734202701
Brand
Livewire™
Company
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Model
401942
Catalog number
401942
Device description
Steerable Electrophysiology Catheter
Published
2023-10-31
Public version status
Update
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
DRACATHETER, STEERABLE
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRACatheter, SteerableCardiovascular2
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734202701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734202701054147342027015414734202701

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping catheter, percutaneous, single-useA sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry, keep away from sunlight, protect from heat and radioactive sources

Contacts#

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

Regulatory Flags#

DUNS number
040960379
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
true
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
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
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
05414734001076Pacel™4017674017672015-07-31

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Primary DI, Brand, Company table
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