Reocor D Redeladapter

Primary DI
04035479114336
Brand
Reocor D Redeladapter
Company
BIOTRONIK SE & Co. KG
Model
371262
Catalog number
371262
Published
2014-08-21
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
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479114336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479114336040354791143364035479114336

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 Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
315620229
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479110048Reocor S3655283655282014-08-13
04035479110055Reocor D3655293655292014-08-13
04035479114343Reocor S Redeladapter3712633712632014-08-21
04035479114510Renamic PGH3715883715882014-08-21
04035479114527Renamic PGH ICD3715893715892014-08-21
04035479115142Renamic3719603719602014-08-12
04035479126391Renamic PSA Module3866103866102014-08-15
04035479143848Home Monitoring Service Center3.274053312014-08-21
04035479144241Home Monitoring Service Center3.284055522014-09-19
04035479144791BS IS-13308343308342014-08-04
04035479144807DH3316683316682014-08-14
04035479144968S 45-K1135881135882014-08-14
04035479144975S 45-S1300111300112014-08-14
04035479145019S 53-K1072351072352014-08-14
04035479145026S 53-S1300131300132014-08-14
04035479145033S 58-K1188771188772014-08-21
04035479148836Home Monitoring Service Center3.304084082015-04-22
04035479148850Home Monitoring Service Center3.324084102015-10-20
04035479152406Home Monitoring Service Center3.344193212016-04-18
04035479157821EFH-6F-W4333064333062017-11-22

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
04035479114343Reocor S 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