Consulta® CRT-P
GUDID 00613994713667
CRT C4TR01 CONSULTA CRT-P US MR
MEDTRONIC, INC.
Cardiac resynchronization therapy implantable pacemaker| Primary Device ID | 00613994713667 |
| NIH Device Record Key | ee35bcab-7776-4675-94f9-d63ab466f7c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Consulta® CRT-P |
| Version Model Number | C4TR01 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994713667 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P010015
FDA Product Code
| NVZ | Pulse generator, permanent, implantable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-28 |
| Device Publish Date | 2014-09-23 |
Devices Manufactured by MEDTRONIC, INC.
| 20763000982946 - NA | 2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD |
| 00763000984007 - NA | 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG |
| 00763000984021 - NA | 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE |
| 00763000984151 - NA | 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT |
| 00763000984168 - NA | 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS |
| 00763000984175 - NA | 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK |
| 00763000180010 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 693552 SPRINT US RCMCRD |
| 00763000180027 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 693575 SPRINT US RCMCRD |
Trademark Results [Consulta]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CONSULTA 78624569 3613864 Live/Registered |
Medtronic, Inc. 2005-05-06 |
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