FDA.reportPublic FDA data

Eluna 8 HF-T

Primary DI
04035479131753
Brand
Eluna 8 HF-T
Company
BIOTRONIK SE & Co. KG
Model
394917
Catalog number
394917
Published
2014-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKEPulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950037137

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950037137DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSBiotronik, Inc.1996-10-11DXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479131753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479131753040354791317534035479131753

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac resynchronization therapy implantable pacemakerA 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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature14 Degrees Fahrenheit113 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
Serial number
true
Expiration date on label
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
05415067049575Merlin™ST. JUDE MEDICAL, INC.NKE2025-06-25
05415067050045Neutrino™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NKE2024-11-13
04035479174002Amvia Edge HF-T QPBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174033Amvia Sky HF-TBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174040Amvia Sky HF-T QPBIOTRONIK SE & Co. KGNKE2023-07-12
05415067040404NAST. JUDE MEDICAL, INC.NKE2023-01-09
00763000688479NAMEDTRONIC, INC.NKE2022-10-28
05415067031174Merlin™ST. JUDE MEDICAL, INC.NKE2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.NKE2022-08-29
05414734510080Quadra Allure™ST. JUDE MEDICAL, INC.NKE2019-01-15
05414734510097Quadra Allure MP™ST. JUDE MEDICAL, INC.NKE2019-01-15
00763000060428NAMEDTRONIC, INC.NKE2018-12-16
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