Sprint Quattro Secure®

GUDID 00643169082229

LEAD 6947M49 DF4 ACTIVE DC US EN

MEDTRONIC, INC.

Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead
Primary Device ID00643169082229
NIH Device Record Keycf28d7ff-1727-4aab-b28c-9abf393e01dc
Commercial Distribution Discontinuation2018-06-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSprint Quattro Secure®
Version Model Number6947M49
Company DUNS006261481
Company NameMEDTRONIC, 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 Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169082229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVYPermanent defibrillator electrodes

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-13
Device Publish Date2014-09-23

On-Brand Devices [Sprint Quattro Secure®]

00613994250094LEAD 6947100 US FPA QUAD
00613994249890LEAD 694765 US FPA QUAD
00613994249876LEAD 694758 US FPA QUAD
00643169082304LEAD 6947M97 DF4 ACTIVE DC US EN
00643169082281LEAD 6947M72 DF4 ACTIVE DC US EN
00643169082267LEAD 6947M62 DF4 ACTIVE DC US EN
00643169082243LEAD 6947M55 DF4 ACTIVE DC US EN
00643169082229LEAD 6947M49 DF4 ACTIVE DC US EN
00643169309746LEAD 6947M97 SPRINT USA DF4 MCRD NG ACI
00643169309739LEAD 6947M72 SPRINT USA DF4 MCRD NG ACI
00643169309722LEAD 6947M62 SPRINT USA DF4 MCRD NG ACI
00643169309715LEAD 6947M55 SPRINT USA DF4 MCRD NG ACI
00643169309708LEAD 6947M49 SPRINT USA DF4 MCRD NG ACI

Trademark Results [Sprint Quattro Secure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPRINT QUATTRO SECURE
SPRINT QUATTRO SECURE
78030444 2820385 Live/Registered
MEDTRONIC, INC.
2000-10-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.