This page includes the latest FDA filings for Xvivo Perfusion Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| SWEDEN | STOCKHOLM STOCK EXCHANGE | XVIVO | DUNS 559895730 |
| Registration Number | 3007710603 |
| FEI Number | 3007710603 |
| Name | Christopher Toomes |
| Owner & Operator | XVIVO Perfusion AB |
| Contact Address | 3666 South Inca Street Englewood CO 80110 US |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 3666 South Inca Street Englewood, CO 80110 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| Xvivo Perfusion AB | XVIVO Disposable Lung Kit 19046 | 2023-10-09 |
XVIVO Perfusion AB | KIDNEY ASSIST-transport | 2022-01-20 |
| Xvivo Perfusion AB | XVIVO Click Adapter 19024 | 2021-11-08 |
| Xvivo Perfusion AB | XVIVO Lung Cannula Set II™ 19023 | 2021-10-11 |
| Xvivo Perfusion AB | PERFADEX Plus (Click US) 19850 | 2019-12-12 |
| Xvivo Perfusion AB | PERFADEX Plus® 19900 | 2019-12-12 |
| Xvivo Perfusion AB | PERFADEX Plus® 19800 | 2019-12-12 |
| Xvivo Perfusion AB | XVIVO Perfusion System (XPS™) 19030 | 2019-12-05 |
| Xvivo Perfusion AB | Perfadex with THAM 19018 | 2019-12-05 |
| Xvivo Perfusion AB | Perfadex with THAM 19017 | 2019-12-05 |
Christopher Toomes [XVIVO Perfusion AB] | XVIVO PGM | 2019-11-23 |
Christopher Toomes [XVIVO Perfusion AB] | XVIVO Organ Chamber | 2019-11-23 |
Christopher Toomes [XVIVO Perfusion AB] | XVIVO Lung Cannula Set | 2019-11-23 |
Christopher Toomes [XVIVO Perfusion AB] | XVIVO Disposable Kit | 2019-11-23 |
Christopher Toomes [XVIVO Perfusion AB] | XPS | 2019-11-23 |
Christopher Toomes [XVIVO Perfusion AB] | XPS Disposable Lung Circuit | 2019-11-23 |
Christopher Toomes [XVIVO Perfusion AB] | STEEN Solution | 2019-11-23 |
Christopher Toomes [XVIVO Perfusion AB] | Perfadex Plus | 2019-11-23 |
| Xvivo Perfusion AB | XVIVO Click Adapter 19125 | 2019-04-23 |
| Xvivo Perfusion AB | Silicon Tubing Set 19005 | 2019-04-23 |
| Xvivo Perfusion AB | PERFADEX® Plus 19950 | 2018-10-22 |
XVIVO Perfusion AB | Perfadex Plus | 2018-06-22 |
| Xvivo Perfusion AB | XVIVO Lung Disposables Kit 19035 | 2018-03-29 |
| Xvivo Perfusion AB | XVIVO PGM Disposable Sensors™ 19033 | 2018-03-29 |
| Xvivo Perfusion AB | XVIVO Lung Cannula Set™ 19022 | 2018-03-29 |
| Xvivo Perfusion AB | XVIVO Organ Chamber™ 19020 | 2018-03-29 |
| Xvivo Perfusion AB | STEEN Solution™ 19004 | 2018-03-29 |
Christopher Toomes [XVIVO Perfusion AB] | Silicone Tubing Set | 2013-05-07 |
XVIVO PERFUSION AB | PERFADEX AND PERFADEX WITH THAM | 2010-10-01 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020071843067 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | ------------ SEGU9544088 DESCRIPTION--------- PERDAFEX SOLUTION FOR LUNG PERFUSION. HEART DISPOSABLE KIT TROLLEY FOR HEART BOX HS 300490, 901890, 392690, 761699,420212 FCL/FCL | 25 PCS |
| 2018122026124 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | ------------ CGMU5107674 DESCRIPTION--------- PERDAFEX SOLUTION FOR LUNG PERFUSION HS: 300390 -------------GENERIC DESCRIPTION------------- CARGO IS STOWED IN A REFRIGERATED CONTAINER S AT THE SHIPPER'S REQUESTED CARRYING TEMPERATU OF 15 DEGREES CELSIUS | 14 PCS |
| 2018121924220 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | ------------ CGMU5107674 DESCRIPTION--------- PERDAFEX SOLUTION FOR LUNG PERFUSION HS: 300390 -------------GENERIC DESCRIPTION------------- CARGO IS STOWED IN A REFRIGERATED CONTAINER S AT THE SHIPPER'S REQUESTED CARRYING TEMPERATU OF 15 DEGREES CELSIUS | 14 PCS |
| 2018091531385 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | ------------ CGMU2993389 DESCRIPTION--------- PERDAFEX SOLUTION FOR LUNG PERFUSION HS CODE : 300490 -------------GENERIC DESCRIPTION------------- CARGO IS STOWED IN A REFRIGERATED CONTAINER S AT THE SHIPPER'S REQUESTED CARRYING TEMPERATU OF 15 DEGREES CELSIUS | 10 PCS |
| 2018032726947 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | ------------ CGMU3034882 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- CARGO IS STOWED IN A REFRIGERATED CONTAINER S AT THE SHIPPER'S REQUESTED CARRYING TEMPERATU OF 15 DEGREES CELSIUS | 34 PCS |
| 2018032726947 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | ------------ TTNU8268019 DESCRIPTION--------- PERDAFEX SOLUTION FOR LUNG PERFUSION HS CODE : 300490 -------------GENERIC DESCRIPTION------------- CARGO IS STOWED IN A REFRIGERATED CONTAINER S AT THE SHIPPER'S REQUESTED CARRYING TEMPERATU OF 15 DEGREES CELSIUS | 34 PCS |
| 2018031437548 | Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina | ------------ CGMU3034882 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- CARGO IS STOWED IN A REFRIGERATED CONTAINER S AT THE SHIPPER'S REQUESTED CARRYING TEMPERATU OF 15 DEGREES CELSIUS | 34 PCS |
| 2018031437548 | Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina | ------------ TTNU8268019 DESCRIPTION--------- PERDAFEX SOLUTION FOR LUNG PERFUSION HS CODE : 300490 -------------GENERIC DESCRIPTION------------- CARGO IS STOWED IN A REFRIGERATED CONTAINER S AT THE SHIPPER'S REQUESTED CARRYING TEMPERATU OF 15 DEGREES CELSIUS | 34 PCS |