Current Accel®

Primary DI
H758CD2215360
Brand
Current Accel®
Company
ST. JUDE MEDICAL, INC.
Model
DR
Catalog number
CD2215-36
Device description
Tiered-therapy cardioverter/defibrillator VVED DDDR
Published
2014-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P910023215

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P910023215CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMABBOTT MEDICAL1993-04-30LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734502641PrimaryGS10
H758CD2215360SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734502641054147345026415414734502641

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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume42Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Store the device away from magnets and sources of electromagnetic interference.
Storage Environment Temperature10 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
790268031
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05415067052780Epic™EELT-27MEELT-27M2026-07-08
05415067052797Epic™ESP300-25ESP300-252026-07-08
05415067052803Epic™ESP300-19ESP300-192026-07-08
05415067052810Epic™EELT-19AEELT-19A2026-07-08
05415067052827Epic™EELT-29MEELT-29M2026-07-08
05415067052834Epic™EELT-27AEELT-27A2026-07-08
05415067052858Epic™EELT-25AEELT-25A2026-07-08
05415067052865Epic™EELT-21AEELT-21A2026-07-08
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Primary DI, Brand, Company table
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