HeartMate 3™ 106531LF2
GUDID 05415067039422
System Controller Low Flow 2.0
Thoratec Corporation
Personal device holder, reusable| Primary Device ID | 05415067039422 |
| NIH Device Record Key | 8d041e12-0570-4966-b063-14ae3c6271c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeartMate 3™ |
| Version Model Number | 106531LF2 |
| Catalog Number | 106531LF2 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067031105 [Previous] |
| GS1 | 05415067039422 [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 | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-24 |
| Device Publish Date | 2025-07-16 |
On-Brand Devices [HeartMate 3™]
| 05415067030269 | Outflow Graft Clip |
| 15415067039481 | Thread Protectors |
| 05415067039361 | Skin Coring Punch |
| 05415067039286 | Apical Cuff |
| 05415067038760 | Coring Tool |
| 05415067039422 | System Controller Low Flow 2.0 |
Trademark Results [HeartMate 3]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEARTMATE 3 86722375 5464938 Live/Registered |
Thoratec Corporation 2015-08-12 |
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