Thoratec® HeartMate 3™ 106528US
GUDID 05415067030825
Skin Coring Punch
Thoratec Corporation
Biopsy punch, reusable Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use Skin-coring punch, single-use| Primary Device ID | 05415067030825 |
| NIH Device Record Key | ab4ab164-88d3-47a4-bab3-38dec4d8d467 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thoratec® HeartMate 3™ |
| Version Model Number | 106528US |
| Catalog Number | 106528US |
| 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 | 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 | 05415067030825 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160054
FDA Product Code
| DSQ | Ventricular (assist) bypass |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-31 |
| Device Publish Date | 2019-05-23 |
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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