Current Accel™ CD1215-36Q

GUDID 05414734503044

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
Primary Device ID05414734503044
NIH Device Record Keyea26de88-4764-4dd2-b3d4-d839ee94a586
Commercial Distribution Discontinuation2018-02-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCurrent Accel™
Version Model NumberVR
Catalog NumberCD1215-36Q
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

Device Dimensions

Total Volume41 Milliliter
Total Volume41 Milliliter
Total Volume41 Milliliter
Total Volume41 Milliliter
Total Volume41 Milliliter
Total Volume41 Milliliter
Total Volume41 Milliliter
Total Volume41 Milliliter
Total Volume41 Milliliter
Total Volume41 Milliliter

Operating and Storage Conditions

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.
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 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
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 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
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 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
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 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
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 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
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 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
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 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
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 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
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 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
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.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734503044 [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 Number6
Public Version Date2020-05-04
Device Publish Date2017-01-24

On-Brand Devices [Current Accel™]

05414734503044Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734502634Tiered-therapy cardioverter/defibrillator VVEV VVIR

Trademark Results [Current Accel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CURRENT ACCEL
CURRENT ACCEL
77412923 3768133 Dead/Cancelled
Pacesetter, Inc.
2008-03-04

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