Primary Device ID | 10803622112857 |
NIH Device Record Key | 811dc13b-bbba-4082-95a1-8943270abdaf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Aortic Root Cannula |
Version Model Number | AR-001USC |
Company DUNS | 080914995 |
Company Name | LIVANOVA USA, 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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00803622112850 [Primary] |
GS1 | 10803622112857 [Package] Contains: 00803622112850 Package: CASE [10 Units] In Commercial Distribution |
DWF | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-08-15 |
Device Publish Date | 2014-12-29 |
00803622156786 - Perfusion Pack | 2024-05-31 |
10803622156820 - Cardioplegia Pack | 2024-05-31 |
00803622156755 - Perfusion Pack | 2024-05-29 |
00803622156762 - Perfusion Pack | 2024-05-29 |
00803622156779 - Perfusion Pack | 2024-05-29 |
00803622156731 - Perfusion Pack | 2024-05-21 |
00803622156618 - Perfusion Pack | 2024-05-14 |
00803622156717 - Perfusion Pack | 2024-05-13 |