This page includes the latest FDA filings for Xvivo Perfusion Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Xvivo Perfusion Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3009736925 |
| FEI Number | 3009736925 |
| Name | XVIVO PERFUSION, INC. |
| Owner & Operator | XVIVO Perfusion, Inc. |
| Contact Address | 3666 South Inca Street Englewood CO 80110 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 3666 S Inca Street Englewood, CO 80110 US |
| Establishment Type | Develop Specifications But Do Not Manufacture At This Facility |
Device Company | Device | Date |
|---|---|---|
| XVIVO Perfusion, Inc. | XVIVO Perfusion System (XPS)™ with STEEN Solution™ Perfusate | 2021-11-03 |
| XVIVO Perfusion, Inc. | XVIVO Perfusion System with STEEN Solution Perfusate | 2020-10-23 |
| XVIVO Perfusion, Inc. | XVIVO Perfusion System (XPS) with STEEN Solution Perfusate | 2020-04-26 |
| XVIVO Perfusion, Inc. | Xvivo Perfusion System (XPS) with Steen Solution Perfusate | 2020-04-24 |
XVIVO PERFUSION, INC. | XVIVO PGM | 2019-11-23 |
XVIVO PERFUSION, INC. | XVIVO Organ Chamber | 2019-11-23 |
XVIVO PERFUSION, INC. | XVIVO Lung Cannula Set | 2019-11-23 |
XVIVO PERFUSION, INC. | XVIVO Disposable Kit | 2019-11-23 |
XVIVO PERFUSION, INC. | XPS | 2019-11-23 |
XVIVO PERFUSION, INC. | XPS Disposable Lung Circuit | 2019-11-23 |
XVIVO PERFUSION, INC. | STEEN Solution | 2019-11-23 |
| XVIVO Perfusion, Inc. | XVIVO Perfusion System (XPS) with STEEN Solution Perfusate | 2019-10-29 |
| XVIVO Perfusion, Inc. | XPS™ with Steen Solution™ Perfusate | 2019-04-26 |
XVIVO PERFUSION, INC. | Perfadex Plus | 2018-09-13 |
XVIVO PERFUSION, INC. | XVIVO Click Adapter | 2018-09-13 |
| 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 |