Sprint Quattro®
GUDID 00613994249951
LEAD 6944-58 US FPA QUAD DSP SOLN
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 ID | 00613994249951 |
| NIH Device Record Key | b5456b07-d203-4740-949f-3e2267ffcce3 |
| Commercial Distribution Discontinuation | 2018-06-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Sprint Quattro® |
| Version Model Number | 6944-58 |
| 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 | true |
| 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 |
Device Dimensions
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994249951 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P920015
FDA Product Code
| NVY | Permanent defibrillator electrodes |
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 | 2018-08-13 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [Sprint Quattro®]
| 00613994249975 | LEAD 6944-65 US FPA QUAD DSP SOLN |
| 00613994249951 | LEAD 6944-58 US FPA QUAD DSP SOLN |
| 00643169451476 | LEAD 6944-100 SPRINT QUATTRO US |
| 00643169451469 | LEAD 6944-65 SPRINT QUATTRO US |
| 00643169451452 | LEAD 6944-75 SPRINT QUATTRO US |
| 00643169440852 | LEAD 6944-58 SPRINT QUATTRO US |
| 00643169335592 | LEAD 6946M97 USA EN SPRINT DF4 PASSIVE |
| 00643169335585 | LEAD 6946M72 USA EN SPRINT DF4 PASSIVE |
| 00643169335578 | LEAD 6946M62 USA EN SPRINT DF4 PASSIVE |
| 00643169335561 | LEAD 6946M55 USA EN SPRINT DF4 PASSIVE |
Trademark Results [Sprint Quattro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPRINT QUATTRO 75758564 2635937 Live/Registered |
Medtronic, Inc. 1999-07-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.