Ellipse™ CD1411-36C

GUDID 05414734507707

Tiered-therapy cardioverter/defibrillator VVEV VVIR

ST. JUDE MEDICAL, INC.

Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator
Primary Device ID05414734507707
NIH Device Record Keyb9c2a0ee-f5be-4bb4-bc65-bdcd3b920bf5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEllipse™
Version Model NumberVR
Catalog NumberCD1411-36C
Company DUNS790268031
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter
Total Volume30.6 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 22 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734507707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVZPulse generator, permanent, implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-27
Device Publish Date2017-04-10

On-Brand Devices [Ellipse™]

05414734507738Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734507721Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734507714Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734507707Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734507615Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734507608Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734507592Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734507585Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734506113Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734506106Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734506038Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734506021Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734505994Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734505987Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734505918Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734505901Tiered-therapy cardioverter/defibrillator VVED DDDR

Trademark Results [Ellipse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ELLIPSE
ELLIPSE
98135926 not registered Live/Pending
Capnova S.A.S.
2023-08-16
ELLIPSE
ELLIPSE
97876535 not registered Live/Pending
Wavegate Corporation
2023-04-06
ELLIPSE
ELLIPSE
97824486 not registered Live/Pending
Harmonic Egg, LLC
2023-03-06
ELLIPSE
ELLIPSE
97324461 not registered Live/Pending
Conair LLC
2022-03-22
ELLIPSE
ELLIPSE
90197271 not registered Live/Pending
Suncast Corporation
2020-09-21
ELLIPSE
ELLIPSE
90010898 not registered Live/Pending
Doctor Fashion, S.A.P.I. de CV
2020-06-19
ELLIPSE
ELLIPSE
88660814 not registered Live/Pending
TELEVES, S.A.
2019-10-18
ELLIPSE
ELLIPSE
87313964 not registered Live/Pending
Velo Labs Inc.
2017-01-25
ELLIPSE
ELLIPSE
86114993 4791293 Live/Registered
EFTON MANAGEMENT, INC.
2013-11-11
ELLIPSE
ELLIPSE
85715347 not registered Dead/Abandoned
Ellipse Technologies, Inc.
2012-08-28
ELLIPSE
ELLIPSE
85424248 not registered Dead/Abandoned
Ainsworth Game Technology Limited
2011-09-16
ELLIPSE
ELLIPSE
85392028 4169296 Live/Registered
Pacesetter, Inc.
2011-08-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.