| Primary Device ID | 05414734309073 |
| NIH Device Record Key | 36ca6e7b-23b7-4639-8eac-5e23b59014ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SJM™ |
| Version Model Number | 1778-E |
| Catalog Number | IBI-85778 |
| Company DUNS | 926346966 |
| Company Name | IRVINE BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| 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 |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Length | 8 Feet |
| Length | 2.5 Meter |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool,dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734309073 [Primary] |
| OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
[05414734309073]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-01-28 |
| Device Publish Date | 2014-10-31 |
| 05414734309349 | 1914-SA |
| 05414734309332 | 1910-SA |
| 05414734309318 | 1904-SA |
| 05414734309172 | 1924-S |
| 05414734309165 | 1910-S |
| 05414734309110 | 1804-S |
| 05414734309080 | IBI-85786 |
| 05414734309073 | 1778-E |
| 05414734309059 | 1776 |
| 05414734308977 | 1763-E |
| 05414734308939 | 1739-W |
| 05414734308854 | 1713-W |
| 05414734308847 | 1711-M |
| 05414734308830 | 1710 |
| 05414734308755 | 1641 |