SPRINT QUATTRO SECURE® DXAC/DSP
GUDID 00643169535954
LEAD 694775 SPRINT QUATTRO US SI MCRD
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 | 00643169535954 |
| NIH Device Record Key | e6084848-3592-47e6-aa5a-df6312fb4a48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPRINT QUATTRO SECURE® DXAC/DSP |
| Version Model Number | 694775 |
| 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 | 75 Centimeter |
| Length | 75 Centimeter |
| Length | 75 Centimeter |
| Length | 75 Centimeter |
| Length | 75 Centimeter |
| Length | 75 Centimeter |
| Length | 75 Centimeter |
| Length | 75 Centimeter |
| Length | 75 Centimeter |
| Length | 75 Centimeter |
| Length | 75 Centimeter |
| Length | 75 Centimeter |
| Length | 75 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 | 00643169535954 [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 | 3 |
| Public Version Date | 2018-08-13 |
| Device Publish Date | 2015-07-10 |
On-Brand Devices [SPRINT QUATTRO SECURE® DXAC/DSP]
| 00613994740939 | LEAD 694775 SPRINT US 75CM FPA QUAD |
| 00613994740922 | LEAD 694765 SPRINT US 65CM FPA QUAD |
| 00613994740915 | LEAD 694758 SPRINT US 58CM FPA QUAD |
| 00613994740908 | LEAD 6947100 SPRINT US 100CM FPA QUAD |
| 00643169535978 | LEAD 6947100 SPRINT QUATTRO US SI MCRD |
| 00643169535961 | LEAD 694758 SPRINT QUATTRO US SI MCRD |
| 00643169535954 | LEAD 694775 SPRINT QUATTRO US SI MCRD |
| 00643169535947 | LEAD 694765 SPRINT QUATTRO US SI MCRD |
Trademark Results [SPRINT QUATTRO SECURE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPRINT QUATTRO SECURE 78030444 2820385 Live/Registered |
MEDTRONIC, INC. 2000-10-13 |
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