Evera MRI™ XT DR SureScan™

Primary DI
00643169717282
Brand
Evera MRI™ XT DR SureScan™
Company
MEDTRONIC, INC.
Model
DDMB1D1
Device description
ICD-DR DDMB1D1 EVERA MRI XT US DF1
Published
2016-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVZPulse Generator, Permanent, ImplantableUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169717282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169717282006431697172826431697172820643169717282

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994963826NIH™0087612016-07-24
00613994964274NIH™ Cardio-Marker0100112016-06-10
00613994964540Lehman™0012592016-06-05
00613994964564Lehman™0012632016-06-05
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00681490860659DLPCB140172016-05-22
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000812058NAMEDTRONIC, INC.NVZ2025-04-12
00763000378356Instrument Command LibraryMEDTRONIC, INC.NVZ2024-05-04
04035479173937BIOTRONIKBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173944BIOTRONIKBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173982BIOTRONIKBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173999BIOTRONIKBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174019BIOTRONIKBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174026BIOTRONIKBIOTRONIK SE & Co. KGNVZ2023-07-12
00763000612665MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
00763000181345NAMEDTRONIC, INC.NVZ2021-06-12
00763000414023MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000414047MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000316785Adapta™MEDTRONIC, INC.NVZ2020-11-28
04035479147686Evity 6 DR-TBIOTRONIK SE & Co. KGNVZ2020-09-15
00763000060015Evera MRI™ S DR SureScan™MEDTRONIC, INC.NVZ2020-09-04
00763000060107Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.NVZ2020-09-04
00763000316808Attesta™ DR MRI SureScan™MEDTRONIC, INC.NVZ2020-07-30
00763000316822Attesta™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2020-07-30
00763000351656TriageHF™MEDTRONIC, INC.NVZ2020-07-23
00763000178376Cobalt™ DR MRI SureScan™MEDTRONIC, INC.NVZ2020-06-08
00763000178413Crome™ DR MRI SureScan™MEDTRONIC, INC.NVZ2020-06-08
00763000178437Crome™ DR MRI SureScan™MEDTRONIC, INC.NVZ2020-06-08
00763000178512Cobalt™ VR MRI SureScan™MEDTRONIC, INC.NVZ2020-06-08
00763000178536Crome™ VR MRI SureScan™MEDTRONIC, INC.NVZ2020-06-08
00763000178550Crome™ VR MRI SureScan™MEDTRONIC, INC.NVZ2020-06-08
00643169552043MyCareLink™MEDTRONIC, INC.NVZ2019-10-13
00763000033194MyCareLink™MEDTRONIC, INC.NVZ2019-10-13
00763000033217MyCareLink™MEDTRONIC, INC.NVZ2019-10-13
00643169634626Azure™ XT SR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
08031527017174SmartviewMICROPORT CRM SRLNVZ2017-11-23