Pacel™ 401762
GUDID 05414734001045
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Temporary cardiac pacing balloon catheter| Primary Device ID | 05414734001045 |
| NIH Device Record Key | 840284e4-a19a-4890-b2db-c0a14255dbb2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pacel™ |
| Version Model Number | 401762 |
| Catalog Number | 401762 |
| 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 | true |
| 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 a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734001045 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K914185
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 | 2016-01-28 |
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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