Soloist™

GUDID 00763000227562

CATH 44516J SOLOIST W/O CE

MEDTRONIC, INC.

Cardiac mapping catheter, percutaneous, single-use
Primary Device ID00763000227562
NIH Device Record Key3cfd7184-d4ee-4862-8c34-cabab19a0d87
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoloist™
Version Model Number44516J
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 Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000227562 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [Soloist™]

00643169139602CATH 44516U SOLOIST US W/O CE
00643169139596CATH 44516JF SOLOIST US W/O CE
00643169139558CATH 44216U SOLOIST US W/O CE
00643169139541CATH 44216JF SOLOIST US W/O CE
00643169139534CATH 44216J SOLOIST US W/O CE
00643169139510CATH 441016U SOLOIST US W/O CE
00643169139503CATH 441016JF SOLOIST US W/O CE
00763000227609CATH 441016U SOLOIST W/O CE
00763000227593CATH 44216J SOLOIST W/O CE
00763000227586CATH 44216JF SOLOIST W/O CE
00763000227579CATH 44216U SOLOIST W/O CE
00763000227562CATH 44516J SOLOIST W/O CE
00763000227555CATH 44516U SOLOIST W/O CE
00763000227548CATH 448142J SOLOIST JOSEPH W/O CE

Trademark Results [Soloist]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOLOIST
SOLOIST
98327917 not registered Live/Pending
Starbuzz Tobacco, Inc.
2023-12-22
SOLOIST
SOLOIST
98085490 not registered Live/Pending
Busick, Parker E
2023-07-14
SOLOIST
SOLOIST
97895203 not registered Live/Pending
Liang Xuexing
2023-04-18
SOLOIST
SOLOIST
97775423 not registered Live/Pending
Conn-Selmer, Inc.
2023-01-31
SOLOIST
SOLOIST
97074203 not registered Live/Pending
JACKSON/CHARVEL MANUFACTURING, INC.
2021-10-14
SOLOIST
SOLOIST
90618051 not registered Live/Pending
Cervélo USA, Inc.
2021-04-01
SOLOIST
SOLOIST
87445455 not registered Live/Pending
Adveris, LLC
2017-05-11
SOLOIST
SOLOIST
87443738 5449984 Live/Registered
Adveris, LLC
2017-05-10
SOLOIST
SOLOIST
86268537 5161440 Live/Registered
Precept Brands LLC
2014-05-01
SOLOIST
SOLOIST
78928276 3289115 Dead/Cancelled
DIRECTED, LLC
2006-07-12
SOLOIST
SOLOIST
78642061 3313718 Live/Registered
Boston Scientific Scimed, Inc.
2005-06-02
SOLOIST
SOLOIST
78417989 3007996 Live/Registered
Aerotech, Inc.
2004-05-13

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