OPTIS™ 1014935

GUDID 05415067036858

Integrated Next Upgrade Kit

ST. JUDE MEDICAL, INC.

Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system
Primary Device ID05415067036858
NIH Device Record Keyd54ce0ef-9b47-4f49-9ec8-7b8e4a71ae85
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPTIS™
Version Model Number1014935
Catalog Number1014935
Company DUNS149818952
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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

Operating and Storage Conditions

Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067036858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQQSYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-18
Device Publish Date2021-06-10

On-Brand Devices [OPTIS™]

05415067037558Imaging System
05415067036858Integrated Next Upgrade Kit
05415067036742Mobile Next Upgrade Kit
05415067036643Integrated Next
05415067036629Mobile Next
05415067037268Integrated Pre-Installation Kit
05415067037183Mobile Next Connectivity Box FRU
05415067037169Mobile Installation Kit
05415067037145Integrated Next Imaging System
05415067033680Tableside Controller Next
05415067036728OPTISi Next Monitor
05415067036704OPTISi Next DOC
05415067036681OPTISm Next DOC

Trademark Results [OPTIS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTIS
OPTIS
97761187 not registered Live/Pending
FEI Company
2023-01-19
OPTIS
OPTIS
90897286 not registered Live/Pending
OPTIS Consulting Network, Inc.
2021-08-23
OPTIS
OPTIS
90721714 not registered Live/Pending
OPTIS Consulting Network, Inc.
2021-05-19
OPTIS
OPTIS
90596080 not registered Live/Pending
IMPERATIVE CHEMICAL PARTNERS INC.
2021-03-23
OPTIS
OPTIS
90596039 not registered Live/Pending
IMPERATIVE CHEMICAL PARTNERS INC.
2021-03-23
OPTIS
OPTIS
90265445 not registered Live/Pending
Fiserv, Inc.
2020-10-20
OPTIS
OPTIS
86708532 not registered Dead/Abandoned
LightLab Imaging, Inc.
2015-07-29
OPTIS
OPTIS
86405789 not registered Dead/Abandoned
Castrol Limited
2014-09-25
OPTIS
OPTIS
86060611 4653967 Live/Registered
LightLab Imaging, Inc.
2013-09-10
OPTIS
OPTIS
85842582 4764931 Live/Registered
LightLab Imaging, Inc.
2013-02-06
OPTIS
OPTIS
85695805 4389443 Live/Registered
LightLab Imaging, Inc.
2012-08-06
OPTIS
OPTIS
85672853 4603929 Live/Registered
Options & Choices, Inc.
2012-07-10

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