EnSite™ Velocity™ H702323

GUDID 05415067023230

Utility Upgrade Kit

ST. JUDE MEDICAL, INC.

Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software Cardiac mapping system application software
Primary Device ID05415067023230
NIH Device Record Key88473f97-32ae-4d2c-a79a-f6e6e24dfed5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnSite™ Velocity™
Version Model NumberH702323
Catalog NumberH702323
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [Primary]
GS105415067023230 [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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.