FDA.report

Ilesto 7 DR-T

Primary DI
04035479125196
Brand
Ilesto 7 DR-T
Company
BIOTRONIK SE & Co. KG
Model
383563
Catalog number
383563
Published
2014-08-07
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
MRMDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Product Code Classifications

CodeDeviceSpecialtyClass
MRMDefibrillator, Implantable, Dual-ChamberUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04035479125196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04035479125196040354791251964035479125196

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
Special Storage Condition, Specify00
Storage Environment Temperature41 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags

DUNS number
315620229
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
true
Donation ID number
false
Contains natural rubber latex
false
Sterilization required before use
false

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