Primary Device ID | 00888707005371 |
NIH Device Record Key | 446603e6-e641-473e-8b82-b08e277e028c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HVAD® Pump Implant Accessories |
Version Model Number | MCS1753AK |
Catalog Number | MCS1753AK |
Company DUNS | 146054536 |
Company Name | Heartware Inc. |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00888707005371 [Primary] |
DSQ | Ventricular (Assist) Bypass |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-12-22 |
Device Publish Date | 2020-12-14 |
00888707000147 | 1153 |
00888707005371 | MCS1753AK |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HVAD 85758552 not registered Dead/Abandoned |
HeartWare Inc. 2012-10-19 |
HVAD 78910214 3730135 Live/Registered |
HeartWare, Inc. 2006-06-16 |