Primary Device ID | 10803622128360 |
NIH Device Record Key | 64cca759-e637-49fb-b1b1-5247738302af |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Prime Set |
Version Model Number | AX-xxxxx |
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 | 00803622128363 [Primary] |
GS1 | 10803622128360 [Package] Contains: 00803622128363 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 | 2015-09-22 |
00803622152696 - Perfusion Pack | 2024-12-23 |
00803622158223 - Perfusion Pack | 2024-12-23 |
00803622158247 - Perfusion Pack | 2024-12-23 |
10803622158190 - Perfusion Pack | 2024-12-11 |
10803622158053 - Perfusion Pack | 2024-11-29 |
00803622158131 - Perfusion Pack | 2024-11-29 |
10803622158145 - Perfusion Pack | 2024-11-29 |
10803622158152 - Perfusion Pack | 2024-11-29 |