Reocor S Redeladapter

Primary DI
04035479114343
Brand
Reocor S Redeladapter
Company
BIOTRONIK SE & Co. KG
Model
371263
Catalog number
371263
Published
2014-08-21
Public version status
Update
Distribution status
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
P950037084

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950037084DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSBiotronik, Inc.1996-10-11DXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479114343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479114343040354791143434035479114343

GMDN Terms#

Term, Definition table
TermDefinition
External pacemaker, transcutaneous pacingAn external pulse generator (EPG) designed to generate electrical cardiac pacing impulses to stimulate the entire heart simultaneously (in contrast to single- or dual-chambered invasive pacing) to resuscitate the patient, restore normal cardiac rhythm, and/or temporarily pace the heart during invasive procedures that may induce cardiac arrhythmias or asystole (cardiac standstill). The electrical impulses from the device are usually applied to the surface of the chest through cutaneous leads/electrodes (transcutaneous cardiac stimulation).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit

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
04035479143183Model 3145BIOTRONIK 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