Isoflex™ 1944-46
GUDID 05414734502313
Pacing Lead
ST. JUDE MEDICAL, INC.
Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead| Primary Device ID | 05414734502313 |
| NIH Device Record Key | bdc69de5-208c-4790-b9d0-62a6fe4b2c55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Isoflex™ |
| Version Model Number | 1944-46 |
| Catalog Number | 1944-46 |
| Company DUNS | 790268031 |
| Company Name | ST. JUDE MEDICAL, 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 | 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 | |
| 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 | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
| Length | 46 Centimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 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 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 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734502313 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P960030
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 | 2018-07-06 |
| Device Publish Date | 2017-01-25 |
On-Brand Devices [Isoflex™]
| 05414734502351 | Pacing Lead |
| 05414734502344 | Pacing Lead |
| 05414734502337 | Pacing Lead |
| 05414734502320 | Pacing Lead |
| 05414734502313 | Pacing Lead |
Trademark Results [Isoflex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISOFLEX 97328329 not registered Live/Pending |
Sinomax USA, Inc. 2022-03-24 |
 ISOFLEX 90648031 not registered Live/Pending |
Honeywell International Inc. 2021-04-15 |
 ISOFLEX 88741936 not registered Live/Pending |
Flexitallic Investments, Inc. 2019-12-30 |
 ISOFLEX 87425768 not registered Dead/Abandoned |
Nomaco Inc. 2017-04-26 |
 ISOFLEX 87022827 5800690 Live/Registered |
ALP SUPPLY, INC. 2016-05-03 |
 ISOFLEX 86807719 4983140 Live/Registered |
Dash Medical Gloves, Inc. 2015-11-03 |
 ISOFLEX 85857439 not registered Dead/Abandoned |
totes Isotoner Corporation 2013-02-22 |
 ISOFLEX 85857431 4507566 Live/Registered |
totes Isotoner Corporation 2013-02-22 |
 ISOFLEX 85202793 not registered Dead/Abandoned |
Triad Bellows Design & Mfg Inc 2010-12-21 |
 ISOFLEX 85037841 3986957 Dead/Cancelled |
Britax Child Safety, Inc. 2010-05-13 |
 ISOFLEX 79191355 5243391 Live/Registered |
Chemische Werke Kluthe GmbH 2016-04-07 |
 ISOFLEX 78972985 not registered Dead/Abandoned |
Hickory Springs Manufacturing Company 2006-09-13 |
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