FDA.reportPublic FDA data

Intica Neo 5 DR-T DF-1 ProMRI

Primary DI
04035479156947
Brand
Intica Neo 5 DR-T DF-1 ProMRI
Company
BIOTRONIK SE & Co. KG
Model
429568
Catalog number
429568
Published
2019-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRMDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRMDefibrillator, Implantable, Dual-ChamberUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479156947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479156947040354791569474035479156947

GMDN Terms#

Term, Definition table
TermDefinition
Dual-chamber implantable defibrillatorAn implantable pulse generator with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), that delivers an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate and to pace the heart in cases of bradycardia. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected leads that are positioned inside or on two same-side heart chambers (atrium and ventricle) to monitor the ECG and to automatically deliver the electrical impulse. The device has internal batteries that provide the energy to deliver the impulses; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 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
04035479182755Rivacor Sky DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
04035479182823Acticor Sky DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
04035479183004Rivacor Aura DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
04035479183042Rivacor Rise DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
08031527019611CPR4MICROPORT CRM SRLMRM2023-06-26
08031527017334Smart ECGMICROPORT CRM SRLMRM2021-10-14
04035479156749Ilivia Neo 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2019-09-10
04035479156848Intica Neo 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2019-09-10
04035479156695Acticor 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479156794Rivacor 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479156893Rivacor 5 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479156992Rivacor 3 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479142094Ilivia 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2018-12-13
04035479142100Ilivia 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2017-05-18
08031527015460PLATINIUMMICROPORT CRM SRLMRM2016-09-09
08031527015477PLATINIUMMICROPORT CRM SRLMRM2016-09-09
08031527015514PLATINIUMMICROPORT CRM SRLMRM2016-09-09
08031527015521PLATINIUMMICROPORT CRM SRLMRM2016-09-09
04035479128777Iperia 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2016-01-07
04035479128913Iperia 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2016-01-07
08031527014654Remote Monitoring SystemMICROPORT CRM SRLMRM2015-10-05
08031527012827IntensiaMICROPORT CRM SRLMRM2015-02-20
08031527012834IntensiaMICROPORT CRM SRLMRM2015-02-20
04035479128784Iperia 7 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128807Itrevia 7 DR-T DF-1BIOTRONIK SE & Co. KGMRM2015-02-18
04035479128838Iperia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128852Itrevia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128883Iperia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128906Itrevia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128920Iperia 7 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18