DEVICE: Ellipse™ (05414734507585)
Device Identifier (DI) Information
Ellipse™
CD2411-36C
In Commercial Distribution
CD2411-36C
ST. JUDE MEDICAL, INC.
CD2411-36C
In Commercial Distribution
CD2411-36C
ST. JUDE MEDICAL, INC.
Tiered-therapy cardioverter/defibrillatorVVED DDDR
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
37265 | Dual-chamber implantable defibrillator |
A 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).
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NVZ | Pulse generator, permanent, implantable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference. |
Storage Environment Temperature: exactly 22 Degrees Celsius |
Storage Environment Temperature: exactly 72 Degrees Fahrenheit |
Handling Environment Temperature: between -20 and 60 Degrees Celsius |
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 30.8 Milliliter |
Device Record Status
448bc031-8d95-4f6d-a4be-63a9d214248b
February 23, 2022
9
April 10, 2017
February 23, 2022
9
April 10, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com