FDA.report

Crome™ DR MRI SureScan™

Primary DI
00763000178413
Brand
Crome™ DR MRI SureScan™
Company
MEDTRONIC, INC.
Model
DDPC3D1
Device description
ICD DDPC3D1 CROME DR MRI DF1
Published
2020-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NVZPulse generator, permanent, implantable

Product Code Classifications

CodeDeviceSpecialtyClass
NVZPulse Generator, Permanent, ImplantableUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000178413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000178413007630001784137630001784130763000178413

GMDN Terms

TermDefinition
Dual-chamber implantable defibrillatorA battery-powered, hermetically-sealed pulse generator with a cardiac rhythm recognition system intended to collect and analyse electrocardiogram (ECG) data and deliver appropriate electrical impulses to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and to pace the heart (to treat bradycardia). It is implanted in a pouch beneath the skin of the patient's chest or abdomen and intended to be used with leads that are positioned inside the right atrium and right ventricle to monitor the ECG and to automatically deliver the electrical impulse; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

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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