Pacel™ 401766
GUDID 15414734001059
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter Temporary cardiac pacing catheter| Primary Device ID | 15414734001059 |
| NIH Device Record Key | 9753c88f-f179-4f05-b4bb-28ef0bb50bb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pacel™ |
| Version Model Number | 401766 |
| Catalog Number | 401766 |
| Company DUNS | 040960379 |
| Company Name | ST. JUDE MEDICAL CARDIOVASCULAR DIVISION |
| 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 | false |
| Single Use | true |
| 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 |
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 |
Device Dimensions
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place. Keep dry and keep away from sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734001052 [Primary] |
| GS1 | 15414734001059 [Package] Contains: 05414734001052 Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K875059
FDA Product Code
| LDF | ELECTRODE, PACEMAKER, TEMPORARY |
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 | 2015-07-31 |
On-Brand Devices [Pacel™]
| 15414734027288 | 401769 |
| 15414734026519 | 401765 |
| 05414734022521 | 401764 |
| 05414734021906 | 401761 |
| 05414734007856 | 401763 |
| 15414734001233 | 401776 |
| 15414734001219 | 401775 |
| 15414734001196 | 401774 |
| 15414734001172 | 401773 |
| 15414734001158 | 401772 |
| 15414734001134 | 401771 |
| 15414734001110 | 401770 |
| 15414734001097 | 401768 |
| 15414734001073 | 401767 |
| 15414734001059 | 401766 |
| 05414734001045 | 401762 |
Trademark Results [Pacel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PACEL 73760069 1539220 Live/Registered |
DAIG CORPORATION 1988-10-27 |
 PACEL 73222307 1139867 Dead/Cancelled |
Daig Corporation 1979-07-05 |
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