Thoratec® HeartMate 3™ Sealed Outflow Graft with Bend Relief 105581US
GUDID 00813024013266
Thoratec Corporation
Implantable ventricular circulatory assist system outflow cannula, animal-derived| Primary Device ID | 00813024013266 |
| NIH Device Record Key | 863115ce-cf41-497e-877d-0ddc84e6660c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thoratec® HeartMate 3™ Sealed Outflow Graft with Bend Relief |
| Version Model Number | 105581US |
| Catalog Number | 105581US |
| Company DUNS | 070156955 |
| Company Name | Thoratec Corporation |
| 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 | 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 | |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813024013266 [Primary] |
| GS1 | 05415067038456 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160054
FDA Product Code
| DSQ | Ventricular (Assisst) Bypass |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2017-08-30 |
Devices Manufactured by Thoratec Corporation
| 05415067038296 - HeartMate™ | 2025-04-10 ICU Cover |
| 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 |
Trademark Results [Thoratec]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THORATEC 85978341 4401802 Live/Registered |
Thoratec Corporation 2011-05-19 |
 THORATEC 85324767 not registered Dead/Abandoned |
Thoratec Corporation 2011-05-19 |
 THORATEC 74723471 2052014 Dead/Cancelled |
Thoratec Laboratories Corporation 1995-08-30 |
 THORATEC 74353279 1794636 Live/Registered |
THORATEC CORPORATION 1993-01-28 |
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