FDA.reportPublic FDA data

Pacel™

Primary DI
05414734001137
Brand
Pacel™
Company
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Model
401771
Catalog number
401771
Device description
Bipolar Pacing Catheter
Published
2015-07-31
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
LDFELECTRODE, PACEMAKER, TEMPORARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDFElectrode, Pacemaker, TemporaryCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15414734001134PackageGS15In Commercial Distribution
05414734001137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541473400113415414734001134
05414734001137054147340011375414734001137

GMDN Terms#

Term, Definition table
TermDefinition
Temporary cardiac pacing catheterA sterile, flexible tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker which generates the electrical pacing impulses. It may be unipolar or bipolar and facilitates the display of the electrocardiographic signal. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dark, dry place. Keep dry and keep away from sunlight.

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734202398Livewire™4016524016522015-02-06
05414734001052Pacel™4017664017662015-07-31
05414734001076Pacel™4017674017672015-07-31
05414734001090Pacel™4017684017682015-07-31
05414734001113Pacel™4017704017702015-07-31
05414734001151Pacel™4017724017722015-07-31
05414734001175Pacel™4017734017732015-07-31
05414734001199Pacel™4017744017742015-07-31
05414734001212Pacel™4017754017752015-07-31
05414734001236Pacel™4017764017762015-07-31
05414734026512Pacel™4017654017652015-07-31
05414734027281Pacel™4017694017692015-07-31
05414734001045Pacel™4017624017622016-01-28
05414734007856Pacel™4017634017632016-01-28
05414734021906Pacel™4017614017612016-01-28
05414734022521Pacel™4017644017642016-01-28
05414734205153BRK™G407211G4072112015-11-13
05414734202183Livewire™4015754015752015-02-06
05414734202244Livewire™4015814015812015-02-06
05414734202251Livewire™4015824015822015-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507166Bipolar Pacing CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.LDF2026-05-04
10801902216110ARROWTELEFLEX INCORPORATEDLDF2023-07-14
10801902198386ARROWTELEFLEX INCORPORATEDLDF2022-11-18
08718627412701MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2016-04-25
08718627411674MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411698MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411711MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411735MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411759MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411773MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411797MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411810MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411834MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411858MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411872MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411896MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411919MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411933MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411957MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411971MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411995MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412015MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412039MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412053MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412077MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412091MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412114MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412138MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412152MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412176MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11