FDA.reportPublic FDA data

Evera™ S DR

Primary DI
00643169018044
Brand
Evera™ S DR
Company
MEDTRONIC, INC.
Model
DDBC3D1
Device description
ICD-DR DDBC3D1 EVERA S US IS1/DF1
Published
2014-09-23
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
LWSImplantable cardioverter defibrillator (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169018044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169018044006431690180446431690180440643169018044

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 Temperature0 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19
00199150084067MiniMed Extended Supply KitMMT-445C2026-07-19
00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479182779Rivacor Sky VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
04035479182793Rivacor Sky VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479182830Acticor Sky VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
04035479182847Acticor Sky VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183011Rivacor Aura VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183059Rivacor Rise VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183066Rivacor Rise VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479185695Rivacor Aura VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
05415067049575Merlin™ST. JUDE MEDICAL, INC.LWS2025-06-25
05414734500586NAST. JUDE MEDICAL, INC.LWS2025-05-07
05415067050045Neutrino™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWS2024-11-13
00763000180010Sprint Quattro Secure S™MEDTRONIC, INC.LWS2024-11-04
00763000180027Sprint Quattro Secure S™MEDTRONIC, INC.LWS2024-11-04
00763000180041Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.LWS2024-11-04
00763000180058Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.LWS2024-11-04
00763000180256Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.LWS2024-11-04
00802526623400NABOSTON SCIENTIFIC CORPORATIONLWS2024-08-29
05415067049414Entrant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049421Gallant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049469Entrant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049476Gallant™ST. JUDE MEDICAL, INC.LWS2024-04-25
00763000369736Epsila EV™MEDTRONIC, INC.LWS2023-11-03
00763000369743Epsila EV™MEDTRONIC, INC.LWS2023-11-03
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.LWS2023-11-02