FDA.report

Evia HF

Primary DI
04035479118358
Brand
Evia HF
Company
BIOTRONIK SE & Co. KG
Model
377206
Catalog number
377206
Published
2014-08-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NKEPulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Product Code Classifications

CodeDeviceSpecialtyClass
NKEPulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)Unknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04035479118358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04035479118358040354791183584035479118358

GMDN Terms

TermDefinition
Cardiac resynchronization therapy implantable pacemakerA sterile, battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature14 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04035479189235SW HMSC 3.654966314966312026-01-20
04035479188689SW HMSC 3.634932234932232025-05-07
04035479179687NEO2202.U4735872023-01-16
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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 DIBrandCompanyProduct codePublished
04035479174002BIOTRONIKBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174033BIOTRONIKBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174040BIOTRONIKBIOTRONIK SE & Co. KGNKE2023-07-12
05414734510080QUADRA ALLURE™ST. JUDE MEDICAL, INC.NKE2019-01-15
05414734510097QUADRA ALLURE MP™ST. JUDE MEDICAL, INC.NKE2019-01-15
00643169891401Percepta™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891418Percepta™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891425Serena™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891432Serena™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891449Solara™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891456Solara™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169735637Percepta™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735651Serena™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735675Solara™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735682Solara™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
04035479147563Edora 8 HF-T QPBIOTRONIK SE & Co. KGNKE2017-04-18
04035479147570Edora 8 HF-TBIOTRONIK SE & Co. KGNKE2017-04-18
05414734503785Anthem™ST. JUDE MEDICAL, INC.NKE2017-04-10
00802526559426VISIONIST™ CRT-PBOSTON SCIENTIFIC CORPORATIONNKE2017-03-09
00802526559457VISIONIST™ CRT-PBOSTON SCIENTIFIC CORPORATIONNKE2017-03-09
00802526559471VISIONIST™ X4 CRT-PBOSTON SCIENTIFIC CORPORATIONNKE2017-03-09
05414734502948Frontier™ST. JUDE MEDICAL, INC.NKE2017-02-03
05414734509084QUADRA ALLURE MP™ST. JUDE MEDICAL, INC.NKE2016-03-23
05414734509091QUADRA ALLURE MP™ST. JUDE MEDICAL, INC.NKE2016-03-23
04035479131760Epyra 8 HF-TBIOTRONIK SE & Co. KGNKE2014-12-11
04035479131753Eluna 8 HF-TBIOTRONIK SE & Co. KGNKE2014-12-09
04035479131777Etrinsa 8 HF-TBIOTRONIK SE & Co. KGNKE2014-12-09
00802526559389VALITUDE™ CRT-PBOSTON SCIENTIFIC CORPORATIONNKE2014-11-11