Primary Device ID | 00813024012788 |
NIH Device Record Key | 7408ab41-b1ac-4f64-94e6-992b636bfbc2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HeartMate®, 14V Li-ion Rechargeable Battery Set |
Version Model Number | 2465-US |
Catalog Number | 2465-US |
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 | true |
OTC Over-The-Counter | false |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813024012788 [Primary] |
DSQ | Ventricular (Assisst) Bypass |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-06-20 |
Device Publish Date | 2015-08-06 |
00813024012788 | 2465-US |
00813024010692 | 14V LI-ION RECHARGEABLE BATTERY SET |
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 |