Consulta® CRT-P

GUDID 00613994713667

CRT C4TR01 CONSULTA CRT-P US MR

MEDTRONIC, INC.

Cardiac resynchronization therapy implantable pacemaker
Primary Device ID00613994713667
NIH Device Record Keyee35bcab-7776-4675-94f9-d63ab466f7c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameConsulta® CRT-P
Version Model NumberC4TR01
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 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

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994713667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVZPulse generator, permanent, implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-28
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00199150031610 - NA2025-07-21 CUSTOM PACK BB1U06R24 CHRIS AD
00199150032464 - NA2025-07-21 CUSTOM PACK BB10R35R4 CP PRIME
20199150032482 - NA2025-07-21 CUSTOM PACK 6S19R4 10PK DIALYSIS
00199150033423 - NA2025-07-21 CUSTOM PACK BB12B90R7 SPECTRU
20199150033571 - NA2025-07-21 CUSTOM PACK BB2U59R3 2PK 1/4 TBL L
00199150033614 - NA2025-07-21 CUSTOM PACK BB10J74R14 3/8CNTRIS
00199150034246 - NA2025-07-21 CUSTOM PACK BB11J86R12 ADULT E
00763000925093 - FlexCath Cross™ Transseptal Solution2025-07-21 NDL 900302 FLEXCATH CROSS SL 63CM EIFU

Trademark Results [Consulta]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CONSULTA
CONSULTA
78624569 3613864 Live/Registered
Medtronic, Inc.
2005-05-06

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.