FDA.reportPublic FDA data

GOETZ™ Temporary Pacing Electrode Catheter

Primary DI
00801741011337
Brand
GOETZ™ Temporary Pacing Electrode Catheter
Company
C. R. Bard, Inc.
Model
007157P
Catalog number
007157P
Device description
Goetz Temporary Pacing Electrode Catheter, Bipolar
Published
2015-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBIntroducer, catheter
LDFELECTRODE, PACEMAKER, TEMPORARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2
LDFElectrode, Pacemaker, TemporaryCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741011334PackageGS15In Commercial Distribution
00801741011337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101133410801741011334
00801741011337008017410113378017410113370801741011337

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 Gauge0
Catheter Gauge6French
Length0
Length125Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com
+1(844)823-5433medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
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00801741127625Bard® Leg Bag Holders1501111501112016-08-10
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