FDA.reportPublic FDA data

Safio

Primary DI
04035479113957
Brand
Safio
Company
BIOTRONIK SE & Co. KG
Model
S 60
Catalog number
370946
Published
2014-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479113957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479113957040354791139574035479113957

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial pacing leadAn implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may also transmit electrical responses from the heart back to the pacemaker. The electrode end is normally placed through a vein to contact the wall of one of the heart's chambers (endocardium), and the other end is connected to the pacemaker. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F
Special Storage Condition, Specify00Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F
Storage Environment Temperature077 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
true
Lot or batch
false
Serial number
true
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
04035479177041Solia CSP S 60BIOTRONIK SE & Co. KGNVN2026-02-17
04035479177058Solia CSP S 53BIOTRONIK SE & Co. KGNVN2026-02-17
05415067055514Zenex MRI™ST. JUDE MEDICAL, INC.NVN2026-01-22
05415067050120Entrant™ST. JUDE MEDICAL, INC.NVN2025-02-11
08031527019819VegaMICROPORT CRM SRLNVN2023-06-26
08031527019826VegaMICROPORT CRM SRLNVN2023-06-26
08031527019833VegaMICROPORT CRM SRLNVN2023-06-26
08031527019789VegaMICROPORT CRM SRLNVN2023-06-23
08031527019796VegaMICROPORT CRM SRLNVN2023-06-23
08031527019802VegaMICROPORT CRM SRLNVN2023-06-23
05415067046314UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046321UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046338UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046345UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
00763000740269SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2022-12-11
05415067037275NAST. JUDE MEDICAL, INC.NVN2022-01-07
00763000316778Adapta™MEDTRONIC, INC.NVN2020-11-28
00802526604430INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
00802526604522INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
00802526604577INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
04035479106232SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479106249SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479106256SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479106263SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479118280SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
04035479118297SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
04035479132606SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
04035479136567SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26