FDA.reportPublic FDA data

Crome™ VR MRI SureScan™

Primary DI
00763000178536
Brand
Crome™ VR MRI SureScan™
Company
MEDTRONIC, INC.
Model
DVPC3D1
Device description
ICD DVPC3D1 CROME VR MRI DF1 USA
Published
2020-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWSImplantable cardioverter defibrillator (non-CRT)
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3
NVZPulse Generator, Permanent, ImplantableUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000178536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000178536007630001785367630001785360763000178536

GMDN Terms#

Term, Definition table
TermDefinition
Single-chamber implantable defibrillatorAn implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected a lead(s) that are positioned inside or on one heart chamber (typically right ventricle) to monitor the ECG and to automatically deliver the electrical impulse. It has internal batteries that provide the energy for the discharges; 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
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479173937Solvia Rise SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173944Solvia Rise DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173982Amvia Edge SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173999Amvia Edge DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174019Amvia Sky SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174026Amvia Sky DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
00763000178338Cobalt™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00763000178345Cobalt™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00763000178451Cobalt™ XT VR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00763000178468Cobalt™ XT VR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00643169720589Evera MRI™ S VR SureScan®MEDTRONIC, INC.NVZ2020-11-13
04035479147686Evity 6 DR-TBIOTRONIK SE & Co. KGNVZ2020-09-15
00763000060015Evera MRI™ S DR SureScan™MEDTRONIC, INC.LWS2020-09-04
00763000060060Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.NVZ2020-09-04
00763000060107Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2020-09-04
00763000178376Cobalt™ DR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00763000178390Cobalt™ DR MRI SureScan™MEDTRONIC, INC.NVZ2020-06-08
00763000178413Crome™ DR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00763000178437Crome™ DR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00763000178499Cobalt™ VR MRI SureScan™MEDTRONIC, INC.NVZ2020-06-08
00763000178512Cobalt™ VR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00763000178550Crome™ VR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00643169552272MyCareLink™MEDTRONIC, INC.NVZ2019-08-11
00763000059477NAMEDTRONIC, INC.NVZ2018-12-28
00763000060428NAMEDTRONIC, INC.NVZ2018-12-16
00643169634589Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634602Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634640Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169725379MyCareLink™MEDTRONIC, INC.NVZ2017-11-16
00643169871922Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2017-11-02