FDA.reportPublic FDA data

Secura® DR

Primary DI
00613994446633
Brand
Secura® DR
Company
MEDTRONIC, INC.
Model
D224DRG
Device description
ICD-DR D224DRG Secura DF-1 US
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)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)Unknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994446633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994446633006139944466336139944466330613994446633

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
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

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
04035479182809Acticor Sky HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182816Acticor Sky HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182830Acticor Sky VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
04035479182847Acticor Sky VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479182854Rivacor Sky HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182861Rivacor Sky HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182984Rivacor Aura HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182991Rivacor Aura HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479183011Rivacor Aura VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183028Rivacor Rise HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479183035Rivacor Rise HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
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
05414734509138NAST. JUDE MEDICAL, INC.NIK2026-03-04
05414734506380NAST. JUDE MEDICAL, INC.NIK2025-12-22
05415067049575Merlin™ST. JUDE MEDICAL, INC.LWS2025-06-25
05415067049575Merlin™ST. JUDE MEDICAL, INC.NIK2025-06-25
05414734500586NAST. JUDE MEDICAL, INC.LWS2025-05-07
05415067050045Neutrino™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050045Neutrino™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWS2025-02-11