FDA.reportPublic FDA data

Model 3145

Primary DI
04035479143183
Brand
Model 3145
Company
BIOTRONIK SE & Co. KG
Model
Refurbishment I
Catalog number
371106
Published
2014-08-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVJPulse generator, external pacemaker, dual-chamber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVJPulse Generator, External Pacemaker, Dual ChamberCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950037088

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950037088DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSBiotronik, Inc.1996-10-11DXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479143183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479143183040354791431834035479143183

GMDN Terms#

Term, Definition table
TermDefinition
Implantable pacemaker analyser, intraoperativeAn electronic instrument designed to test an implanted cardiac pacemaker, including the lead/tissue interface at the time of implantation, for invasive pacemaker evaluation and/or during electrophysiology (EP) diagnostic procedures. It has testing and recording capabilities to measure the minimum electrical stimulus needed to elicit ventricular contraction and the minimum intracardiac signal amplitude needed to inhibit the pacemaker (i.e., stimulation and sensing thresholds respectively). It typically includes measuring devices for the bioelectrical signals, a pulse generator, controllers, and the capability to test the characteristics and performance of the implanted pacemaker.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage Environment Atmospheric Pressure 7-15 psi
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity25 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags#

DUNS number
315620229
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479170295Tunneler L4578564578562026-05-28
04035479190538SW HMSC 3.664980924980922026-05-28
04035479182755Rivacor Sky DR-T4819824819822026-04-20
04035479182779Rivacor Sky VR-T DX4819834819832026-04-20
04035479182793Rivacor Sky VR-T4819844819842026-04-20
04035479182809Acticor Sky HF-T QP4819854819852026-04-20
04035479182816Acticor Sky HF-T4819864819862026-04-20
04035479182823Acticor Sky DR-T4819874819872026-04-20
04035479182830Acticor Sky VR-T DX4819884819882026-04-20
04035479182847Acticor Sky VR-T4819894819892026-04-20
04035479182854Rivacor Sky HF-T QP4819904819902026-04-20
04035479182861Rivacor Sky HF-T4819914819912026-04-20
04035479182984Rivacor Aura HF-T QP4820124820122026-04-20
04035479182991Rivacor Aura HF-T4820134820132026-04-20
04035479183004Rivacor Aura DR-T4820144820142026-04-20
04035479183011Rivacor Aura VR-T4820154820152026-04-20
04035479183028Rivacor Rise HF-T QP7820164820162026-04-20
04035479183035Rivacor Rise HF-T4820174820172026-04-20
04035479183042Rivacor Rise DR-T4820184820182026-04-20
04035479183059Rivacor Rise VR-T DX4820194820192026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479143176Model 3145BIOTRONIK SE & Co. KGOVJ2015-10-02
04035479143527Model 3150BIOTRONIK SE & Co. KGOVJ2015-10-01
04035479143534Model 6646BIOTRONIK SE & Co. KGOVJ2015-10-01
04035479143541Model 6653BIOTRONIK SE & Co. KGOVJ2015-10-01
04035479114336Reocor D RedeladapterBIOTRONIK SE & Co. KGOVJ2014-08-21
04035479114343Reocor S RedeladapterBIOTRONIK SE & Co. KGOVJ2014-08-21
04035479143190Model 3145BIOTRONIK SE & Co. KGOVJ2014-08-21
04035479110048Reocor SBIOTRONIK SE & Co. KGOVJ2014-08-13
04035479110055Reocor DBIOTRONIK SE & Co. KGOVJ2014-08-13
04035479110062ReliatyBIOTRONIK SE & Co. KGOVJ2014-08-08