EnSite™ Velocity™ ZMOD-100052576

GUDID 05415067001061

DWS Kit

ST. JUDE MEDICAL, INC.

Utility trolley Utility trolley Utility trolley Utility trolley Utility trolley Utility trolley Utility trolley Utility trolley Utility trolley Utility trolley Utility trolley Utility trolley Utility trolley Utility trolley
Primary Device ID05415067001061
NIH Device Record Key0f7a895b-ad88-4de1-a4f5-c54038cf51b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnSite™ Velocity™
Version Model Number100052576
Catalog NumberZMOD-100052576
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]
GS105415067001061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable
DQKComputer, diagnostic, programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [EnSite™ Velocity™]

05415067026101Software Upgrade Kit, v.5.0.2
05415067023230Utility Upgrade Kit
05415067012258GenConnect
05415067008718Workstation Accessory Kit
05415067001061DWS Kit
05414734031035Workstation

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