FDA.report

Cobalt™ XT HF CRT-D MRI SureScan™

Primary DI
00763000178147
Brand
Cobalt™ XT HF CRT-D MRI SureScan™
Company
MEDTRONIC, INC.
Model
DTPA2D1
Device description
CRTD DTPA2D1 COBALT XT HF MRI DF1
Published
2020-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Product Code Classifications

CodeDeviceSpecialtyClass
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)Unknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000178147PrimaryGS10

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04035479140144Itrevia 5 HF-T QPBIOTRONIK SE & Co. KGNIK2020-10-07
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00763000178185Cobalt™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
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