FDA.reportPublic FDA data

Protecta™ XT CRT-D

Primary DI
00613994714589
Brand
Protecta™ XT CRT-D
Company
MEDTRONIC, INC.
Model
D314TRM
Device description
CRT D314TRM PROTECTA XT CRT-D US MR DF4
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
KRGProgrammer, pacemaker
LWSImplantable cardioverter defibrillator (non-CRT)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRGProgrammer, PacemakerCardiovascular3
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
00613994714589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994714589006139947145896139947145890613994714589

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac resynchronization therapy implantable defibrillatorA sterile, implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].

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
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02
00643169014121INPUT™ PS8933112017-02-02
00643169014138INPUT™ PS8833112017-02-03
00643169014145INPUT™ PS8733112017-02-03
00643169014152INPUT™ PS8633112017-02-02
00643169014169INPUT™ PS8533112017-02-02
00643169014176NA6933112016-08-20
00643169014213NA6633112017-02-02
00643169014220NA6533112017-02-02
00643169014237INPUT™ PS5933112017-02-03
00643169014244INPUT™ PS5833112017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000180256Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.LWS2024-11-04
04035479001575M-50BIOTRONIK SE & Co. KGKRG2024-10-16
00802526623400NABOSTON SCIENTIFIC CORPORATIONLWS2024-08-29
00763000842536NAMEDTRONIC, INC.KRG2023-11-11
00763000369736Epsila EV™MEDTRONIC, INC.LWS2023-11-03
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.LWS2023-11-02
00763000369781Epsila EV™ MRI SureScan™MEDTRONIC, INC.LWS2023-11-02
00763000181185NAMEDTRONIC, INC.KRG2023-01-30
04035479176112DataBridge NABIOTRONIK SE & Co. KGKRG2022-12-14
00763000562786NAMEDTRONIC, INC.LWS2022-11-05
00763000059996Compia MRI™ Quad CRT-D SureScan™MEDTRONIC, INC.NIK2020-09-04
00763000060015Evera MRI™ S DR SureScan™MEDTRONIC, INC.LWS2020-09-04
00763000060091Compia MRI™ CRT-D SureScan™MEDTRONIC, INC.NIK2020-09-04
00763000060107Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2020-09-04
00763000178376Cobalt™ DR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00763000178413Crome™ DR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00763000178437Crome™ DR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00763000178512Cobalt™ VR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00763000178536Crome™ VR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00763000178550Crome™ VR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00763000001513Primo MRI™ DR SureScan™MEDTRONIC, INC.LWS2018-06-02
00763000001551Primo MRI™ VR SureScan™MEDTRONIC, INC.LWS2018-06-02
00763000059545Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-10-21
00763000059545Viva™ XT CRT-DMEDTRONIC, INC.NIK2017-10-21
00763000059569Evera™ XT DRMEDTRONIC, INC.LWS2017-10-21
00763000059651Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-10-21
00763000059651Viva™ Quad XT CRT-DMEDTRONIC, INC.NIK2017-10-21
00763000059668Viva™ XT CRT-DMEDTRONIC, INC.NIK2017-10-21