Tendril MRI™ LPA1200M-58
GUDID 05414734504638
Pacing Lead
ST. JUDE MEDICAL, INC.
Endocardial pacing lead| Primary Device ID | 05414734504638 |
| NIH Device Record Key | caeeae32-3e5f-4992-90df-57ac31da662d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tendril MRI™ |
| Version Model Number | LPA1200M-58 |
| Catalog Number | LPA1200M-58 |
| Company DUNS | 790268031 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| 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(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.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 |
| 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 |
| 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 |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature 25°C (77°F) . |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature 25°C (77°F) . |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature 25°C (77°F) . |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature 25°C (77°F) . |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature 25°C (77°F) . |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature 25°C (77°F) . |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature 25°C (77°F) . |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature 25°C (77°F) . |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature 25°C (77°F) . |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature 25°C (77°F) . |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734504638 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P140033
FDA Product Code
| NVN | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker 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 | 2018-07-06 |
| Device Publish Date | 2017-02-07 |
On-Brand Devices [Tendril MRI™]
| 05414734504683 | Pacing Lead |
| 05414734504638 | Pacing Lead |
| 05414734504621 | Pacing Lead |
Trademark Results [Tendril MRI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENDRIL MRI 77851245 4035531 Live/Registered |
Pacesetter, Inc. 2009-10-18 |
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