FDA.report

Maximo® II DR

Primary DI
00613994446602
Brand
Maximo® II DR
Company
MEDTRONIC, INC.
Model
D284DRG
Device description
ICD-DR D284DRG Maximo II DF-1 US
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

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
00613994446602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994446602006139944466026139944466020613994446602

GMDN Terms

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

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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