HeartMate™ 2465
GUDID 15415067037807
14V Li-ion Rechargeable Battery Set
Thoratec Corporation
Secondary battery| Primary Device ID | 15415067037807 |
| NIH Device Record Key | 839c03b4-0eb5-4abd-a4bb-63e0c419b2de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeartMate™ |
| Version Model Number | 2465 |
| Catalog Number | 2465 |
| 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 | false |
| Serial Number | true |
| 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 |
Operating and Storage Conditions
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813024010692 [Previous] |
| GS1 | 05415067037800 [Primary] |
| GS1 | 15415067037807 [Package] Contains: 05415067037800 Package: [4 Units] In Commercial Distribution |
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 | 2025-05-26 |
| Device Publish Date | 2025-05-16 |
On-Brand Devices [HeartMate™]
| 15415067038279 | ICU Cover |
| 05415067038296 | ICU Cover |
| 15415067039641 | 14V Li-ion Battery Clip Set |
| 05415067039040 | 14V Li-ion Rechargeable Battery Set |
| 05415067038746 | Apical Coring Knife |
| 05415067038609 | Power Module Backup Battery |
| 05415067037824 | Universal Battery Charger |
| 15415067037807 | 14V Li-ion Rechargeable Battery Set |
Trademark Results [HeartMate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEARTMATE 76307678 not registered Dead/Abandoned |
Thoratec Corporation 2001-08-31 |
 HEARTMATE 73701099 1496671 Live/Registered |
THERMEDICS INC. 1987-12-14 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.