Primary Device ID | 00813024012733 |
NIH Device Record Key | 8ae4440b-e1be-47cf-9450-0aeecb247ff3 |
Commercial Distribution Discontinuation | 2018-05-11 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | HeartMate, 14v Li-Ion Battery (SING) |
Version Model Number | 102515-SING |
Catalog Number | 102515-SING |
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 |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com |
Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813024012733 [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 | 2019-03-21 |
Device Publish Date | 2015-08-06 |
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