FDA.reportPublic FDA data

Rivacor Sky DR-T

Primary DI
04035479182755
Brand
Rivacor Sky DR-T
Company
BIOTRONIK SE & Co. KG
Model
481982
Catalog number
481982
Published
2026-04-20
Public version status
New
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
04035479182755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479182755040354791827554035479182755

GMDN Terms#

Term, Definition table
TermDefinition
Dual-chamber implantable defibrillatorA battery-powered, hermetically-sealed pulse generator with a cardiac rhythm recognition system intended to collect and analyse electrocardiogram (ECG) data and deliver appropriate electrical impulses to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and to pace the heart (to treat bradycardia). It is implanted in a pouch beneath the skin of the patient's chest or abdomen and intended to be used with leads that are positioned inside the right atrium and right ventricle to monitor the ECG and to automatically deliver the electrical impulse; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature14 Degrees Fahrenheit113 Degrees Fahrenheit

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
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
04035479183066Rivacor Rise VR-T4820204820202026-04-20
04035479185695Rivacor Aura VR-T DX4871994871992026-04-20
04035479177409BIOTRONIKHomeStreamCP 2100.U4692542023-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04035479156947Intica Neo 5 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