Frontier™ 5586

GUDID 05414734502948

Cardiac Resynchronization Therapy Pacemaker (CRT-P) DDDRV

ST. JUDE MEDICAL, INC.

Cardiac resynchronization therapy implantable pacemaker
Primary Device ID05414734502948
NIH Device Record Keya66324c8-6bc8-49e4-8913-b9d5693cb628
Commercial Distribution Discontinuation2018-02-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFrontier™
Version Model NumberII
Catalog Number5586
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 Volume11.5 Milliliter
Total Volume11.5 Milliliter
Total Volume11.5 Milliliter
Total Volume11.5 Milliliter
Total Volume11.5 Milliliter
Total Volume11.5 Milliliter
Total Volume11.5 Milliliter
Total Volume11.5 Milliliter
Total Volume11.5 Milliliter
Total Volume11.5 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734502948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKEPulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-03

Devices Manufactured by ST. JUDE MEDICAL, INC.

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05415067049889 - Advisor™ HD Grid X, Sensor Enabled™2024-09-02 High Density Mapping Catheter
05415067050182 - Agilis™ NxT Steerable Introducer Dual-Reach™2024-08-23 Steerable Introducer
05415067049704 - EnSite™2024-08-22 X EP System Software Upgrade
05415067049711 - EnSite™2024-08-22 X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade

Trademark Results [Frontier]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FRONTIER
FRONTIER
98812057 not registered Live/Pending
B. ERICKSON MANUFACTURING LTD.
2024-10-21
FRONTIER
FRONTIER
98804843 not registered Live/Pending
Frontier Airlines, Inc.
2024-10-16
FRONTIER
FRONTIER
98668913 not registered Live/Pending
Second Front Systems, Inc.
2024-07-26
FRONTIER
FRONTIER
98275315 not registered Live/Pending
Dressel Holdings LLC
2023-11-17
FRONTIER
FRONTIER
98191739 not registered Live/Pending
Frontier Developments Plc
2023-09-21
FRONTIER
FRONTIER
98158399 not registered Live/Pending
FRONTIER BISCUIT FACTORY PVT. LTD.
2023-08-30
FRONTIER
FRONTIER
98066174 not registered Live/Pending
Kulchitsky, Cody
2023-06-30
FRONTIER
FRONTIER
97978394 not registered Live/Pending
That Was Random, Inc.
2022-11-07
FRONTIER
FRONTIER
97665269 not registered Live/Pending
That Was Random, Inc.
2022-11-07
FRONTIER
FRONTIER
97641007 not registered Live/Pending
Frontier Omni Asset Inc.
2022-10-20
FRONTIER
FRONTIER
97640896 not registered Live/Pending
Frontier Omni Asset Inc.
2022-10-20
FRONTIER
FRONTIER
97539242 not registered Live/Pending
S. Rays, Inc.
2022-08-08
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