Identity™ 5286

GUDID 05414734006828

Pulse Generator DDD

ST. JUDE MEDICAL, INC.

Dual-chamber implantable pacemaker, rate-responsive
Primary Device ID05414734006828
NIH Device Record Key040d0baa-a54f-470e-ab0b-114c2f509e38
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdentity™
Version Model NumberADx XL DC
Catalog Number5286
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

Device Dimensions

Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter
Total Volume11 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
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
GS105414734006828 [Primary]
HIBCCH75852860 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXYimplantable pacemaker Pulse-generator
KRGProgrammer, pacemaker

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-04
Device Publish Date2017-01-25

On-Brand Devices [Identity™]

05414734006903Pulse Generator DDDR
05414734006880Pulse Generator DDDR
05414734006828Pulse Generator DDD

Trademark Results [Identity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IDENTITY
IDENTITY
97823933 not registered Live/Pending
Wenzhou Ouhai Glasses Co., Ltd.
2023-03-06
IDENTITY
IDENTITY
97606470 not registered Live/Pending
Identity, Inc.
2022-09-26
IDENTITY
IDENTITY
97606468 not registered Live/Pending
Identity, Inc.
2022-09-26
IDENTITY
IDENTITY
97364933 not registered Live/Pending
Two Brothers LLC
2022-04-15
IDENTITY
IDENTITY
90831228 not registered Live/Pending
Ililewa Manufacturing, LLC
2021-07-15
IDENTITY
IDENTITY
88754761 not registered Live/Pending
Identity International, LLC
2020-01-10
IDENTITY
IDENTITY
88754752 not registered Live/Pending
Identity International, LLC
2020-01-10
IDENTITY
IDENTITY
88680709 not registered Live/Pending
Zimmer, Inc.
2019-11-05
IDENTITY
IDENTITY
88194477 not registered Dead/Abandoned
Guy, Tyler
2018-11-14
IDENTITY
IDENTITY
88120022 not registered Live/Pending
Identity Management Group, LLC
2018-09-17
IDENTITY
IDENTITY
88104152 not registered Live/Pending
Transparent Agency, LLC
2018-09-04
IDENTITY
IDENTITY
88047074 not registered Dead/Abandoned
Guy, Tyler A
2018-07-20

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