Thoratec® HeartMate 3™ 10010372GBL
GUDID 00813024013143
Tunneling Lance and Handle
Thoratec Corporation
Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller| Primary Device ID | 00813024013143 |
| NIH Device Record Key | 0567a5ac-8431-4487-80bf-df2ecf809659 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thoratec® HeartMate 3™ |
| Version Model Number | 10010372GBL |
| Catalog Number | 10010372GBL |
| 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 | 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 | false |
| 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 |
Operating and Storage Conditions
| Handling 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 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling 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 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling 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 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling 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 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling 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 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling 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 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling 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 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling 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 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813024013143 [Primary] |
| GS1 | 05415067038432 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160054
FDA Product Code
| DSQ | Ventricular (assist) bypass |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
[00813024013143]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-27 |
| Device Publish Date | 2019-03-19 |
On-Brand Devices [Thoratec® HeartMate 3™]
| 00813024013082 | Mini Apical Cuff Kit |
| 00813024013075 | Coring Tool |
| 05415067031105 | System Controller Low Flow 2.0 |
| 05415067030368 | Tunneling Adapter |
| 05415067030825 | Skin Coring Punch |
| 05415067030818 | Thread Protectors |
| 05415067030801 | Apical Cuff |
| 00813024013143 | Tunneling Lance and Handle |
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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