HEARTMATE®, MOBILE POWER UNIT, NA 107754
GUDID 00813024010883
Thoratec Corporation
Basic power supply Basic power supply Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable| Primary Device ID | 00813024010883 |
| NIH Device Record Key | 967a50c7-4ce8-4549-ae90-404ababe4147 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEARTMATE®, MOBILE POWER UNIT, NA |
| Version Model Number | 107754 |
| Catalog Number | 107754 |
| Company DUNS | 070156955 |
| Company Name | Thoratec Corporation |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813024010883 [Primary] |
| GS1 | 05415067038234 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P060040
FDA Product Code
| DSQ | Ventricular (Assisst) Bypass |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-06 |
| Device Publish Date | 2014-09-20 |
Devices Manufactured by Thoratec Corporation
| 15415067038279 - HeartMate™ | 2022-09-20 ICU Cover |
| 05415067042439 - CentriMag™ | 2022-09-07 System Transporter |
| 05415067038760 - HeartMate 3™ | 2022-06-22 Coring Tool |
| 05415067039286 - HeartMate 3™ | 2022-06-22 Apical Cuff |
| 05415067039361 - HeartMate 3™ | 2022-06-22 Skin Coring Punch |
| 15415067039481 - HeartMate 3™ | 2022-06-22 Thread Protectors |
| 05415067033758 - HeartMate Touch™ | 2020-07-02 Communication System |
| 05415067032058 - HeartMate Touch™ | 2020-05-12 Communication System |
Trademark Results [HEARTMATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEARTMATE 76307678 not registered Dead/Abandoned |
Thoratec Corporation 2001-08-31 |
 HEARTMATE 73701099 1496671 Live/Registered |
THERMEDICS INC. 1987-12-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.