FDA.reportPublic FDA data

N/A

Primary DI
10801741011570
Brand
N/A
Company
C. R. Bard, Inc.
Model
106173P
Catalog number
106173P
Device description
OEM Product - Transvenous Pacing Electrodes, Bipolar Balloon Temporary Pacing Electrode Catheter
Published
2015-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10801741011570PackageGS150In Commercial Distribution
00801741011573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101157010801741011570
00801741011573008017410115738017410115730801741011573

GMDN Terms#

Term, Definition table
TermDefinition
Temporary cardiac pacing balloon catheterA sterile, flexible, balloon-tipped, 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 that generates the electrical pacing impulses. It may be unipolar or bipolar and facilitate the display of electrocardiographic signals. 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
Length110Centimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
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
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741011191N/A006172P006172P2015-06-29
00801741011207N/A006173P006173P2015-06-29
00801741011214N/A006221P006221P2015-06-29
00801741011221N/A006225P006225P2015-06-29
00801741011238N/A006241P006241P2015-06-29
00801741011245N/A006242P006242P2015-06-29
00801741011269NBIH™ Temporary Pacing Electrode Catheter007150P007150P2015-06-29
00801741011276NBIH™ Temporary Pacing Electrode Catheter007151P007151P2015-06-29
00801741011283NBIH™ Temporary Pacing Electrode Catheter007152P007152P2015-06-29
00801741011290NBIH™ Temporary Pacing Electrode Catheter007153P007153P2015-06-29
00801741011306GOETZ™ Temporary Pacing Electrode Catheter007154P007154P2015-06-29
00801741011313GOETZ™ Temporary Pacing Electrode Catheter007155P007155P2015-06-29
00801741011320GOETZ™ Temporary Pacing Electrode Catheter007156P007156P2015-06-29
00801741011337GOETZ™ Temporary Pacing Electrode Catheter007157P007157P2015-06-29
00801741011344NBIH™ Temporary Pacing Electrode Catheter007250P007250P2015-06-29
00801741011351NBIH™ Temporary Pacing Electrode Catheter007253P007253P2015-06-29
00801741011368NBIH™ Temporary Pacing Electrode Catheter007406P007406P2015-06-29
00801741011375NBIH™ Temporary Pacing Electrode Catheter007417P007417P2015-06-29
00801741011474NBIH™ Temporary Pacing Electrode Catheter057152P057152P2015-06-29
00801741011481NBIH™ Temporary Pacing Electrode Catheter057153P057153P2015-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056280006SoloPace Fusion Ground PadSOLO PACE INC.LDF2026-02-05
00836559001904Temporary Myocardial HeartwireOscor Inc.LDF2025-09-15
00836559001911Temporary Myocardial HeartwireOscor Inc.LDF2025-09-15
06947437902535MedtronicSHENZHEN LAUNCH ELECTRICAL CO., LTDLDF2025-02-08
20763000181080NAMEDTRONIC, INC.LDF2024-08-30
20801902216117ARROWTELEFLEX INCORPORATEDLDF2023-07-14
20801902198383ARROWTELEFLEX INCORPORATEDLDF2022-11-18
30836559004692Temporary Myocardial HeartwireOscor Inc.LDF2018-08-17
20884521757544FlexonCovidien LPLDF2018-08-10
20884521757551FlexonCovidien LPLDF2018-08-10
20884521757568FlexonCovidien LPLDF2018-08-10
20884521757575FlexonCovidien LPLDF2018-08-10
30705031245741E-PACKETHICON INC.LDF2018-05-10
30705031245697E-PACKETHICON INC.LDF2018-04-05
30705031242306E-PACKETHICON INC.LDF2017-12-06
30705031241859E-PACKETHICON INC.LDF2017-11-29
20836559004022Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
20836559004701Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
20885672102115Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001745Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001752Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001769Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001776Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001790Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001813Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001899Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559003992Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559004609Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559004616Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
00885672004347TBOscor Inc.LDF2017-11-27