Thoratec® HeartMate® ICU Cover (6 Pack) 10002151
GUDID 00813024013495
Thoratec Corporation
Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable| Primary Device ID | 00813024013495 |
| NIH Device Record Key | 2c082dca-0e6a-469a-bd75-4f1b5d710512 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thoratec® HeartMate® ICU Cover (6 Pack) |
| Version Model Number | 10002151 |
| Catalog Number | 10002151 |
| Company DUNS | 070156955 |
| Company Name | Thoratec Corporation |
| Device Count | 6 |
| 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 | 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 | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813024013495 [Primary] |
| GS1 | 05415067030252 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P060040
FDA Product Code
| DSQ | Ventricular (assist) 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 | 3 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2019-05-14 |
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 [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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