FDA.reportPublic FDA data

EFH-25

Primary DI
04035479000769
Brand
EFH-25
Company
BIOTRONIK SE & Co. KG
Model
107622
Catalog number
107622
Published
2014-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTBpermanent pacemaker Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479000769PackageGS110In Commercial Distribution
04035479144852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479000769040354790007694035479000769
04035479144852040354791448524035479144852

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead suture sleeveA small device with a hollow centre that functions as a channel for a pacing or defibrillation lead(s), and is positioned at the point where the surgeon will suture the lead to the patient's tissue to prevent it from moving after the implantation procedure is completed. It is typically made of a silicone rubber material and is implanted with the pacemaker or defibrillator system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Storage Environment Temperature41 Degrees Fahrenheit131 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
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479189211PatientApp 2.94963954963952026-03-04
04035479177041Solia CSP S 604684604684602026-02-17
04035479177058Solia CSP S 534684614684612026-02-17
04035479189235SW HMSC 3.654966314966312026-01-20
04035479188689SW HMSC 3.634932234932232025-05-07
04035479179687NEO2202.U4735872023-01-16
04035479179694PSW2202.U4735882023-01-16
04035479185817Neuro CP app 2300.U4878784878782025-03-27
04035479188733Neuro PR app 2400.U4932414932412025-03-27
04035479184445PatientApp 2.84844484844482025-02-12
04035479187927SW HMSC 3.624918064918062025-01-20
04035479188399NEO 2401.U/14928174928172024-12-18
04035479001575M-501121491121492024-10-16
04035479176143Home Monitoring Service Center3.504597612024-09-20
04035479184636Home Monitoring Service Center3.594860922024-01-10
04035479187163Home Monitoring Service Center3.614906882024-09-03
04035479186005NEO2401.U4883722024-06-17
04035479186012PSW2401.U4883732024-06-17
04035479052515PK-222 US/2,8m3352813352812014-08-20
04035479186128Home Monitoring Service Center3.604886702024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000180041Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180119Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180232Sprint Quattro Secure™MEDTRONIC, INC.DTB2024-11-04
00763000180256Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180263Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180317Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180324Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180331Sprint Quattro Secure™MEDTRONIC, INC.DTB2024-11-04
00763000180348Sprint Quattro Secure™MEDTRONIC, INC.DTB2024-11-04
00763000130800SelectSecure™ MRI SureScan™MEDTRONIC, INC.DTB2018-10-11
00763000130817SelectSecure™ MRI SureScan™MEDTRONIC, INC.DTB2018-10-11
40836559009236Vein PickOscor Inc.DTB2017-11-27
40836559009250Vein PickOscor Inc.DTB2017-11-27
04035479158231EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-22
20885672008349Ligature SleeveOscor Inc.DTB2017-11-18
04035479157838EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-17
00763000014643CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-20
00763000014667CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-20
00763000014711CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-20
00643169453180CapSureFix™ NovusMEDTRONIC, INC.DTB2017-06-02
05414734005715Tendril™ST. JUDE MEDICAL, INC.DTB2017-04-10
00643169448858CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
05414734005777Tendril™ST. JUDE MEDICAL, INC.DTB2017-02-03
05414734501859Tendril™ST. JUDE MEDICAL, INC.DTB2017-02-03
05414734501989Tendril™ST. JUDE MEDICAL, INC.DTB2017-02-03
05414734501996Tendril™ST. JUDE MEDICAL, INC.DTB2017-02-03
05414734504812Tendril™ST. JUDE MEDICAL, INC.DTB2017-02-03
00643169451476SPRINT QUATTRO®MEDTRONIC, INC.DTB2016-07-31