This page includes the latest FDA filings for Gambro Dialysatoren G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 9611369 |
| FEI Number | 3002807035 |
| Name | GAMBRO DIALYSATOREN GMBH |
| Owner & Operator | Gambro Renal Products, Inc. |
| Contact Address | One Baxter Parkway Deerfield IL 60015 US |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | HOLGER - CRAFOORD - STRASSE 26 HECHINGEN Baden-Wurttemberg, 72379 DE |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| Gambro Dialysatoren GmbH | U9000 Plus ultrafilter 955825 | 2022-01-07 |
| Gambro Dialysatoren GmbH | REVACLEAR 114746M | 2021-11-16 |
| Gambro Dialysatoren GmbH | REVACLEAR 114745M | 2021-11-16 |
| Gambro Dialysatoren GmbH | Ultrafilter U 9000 112062 | 2021-04-08 |
| Gambro Dialysatoren GmbH | THERANOVA 955692 | 2020-11-03 |
| Gambro Dialysatoren GmbH | THERANOVA 955691 | 2020-09-10 |
| Gambro Dialysatoren GmbH | Revaclear 114746 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Revaclear 114745 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 103580 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 104176 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 104311 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 104333 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 104329 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 103579 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 103530 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 102057 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 102058 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 103403 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 104324 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 100691 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Polyflux 101785 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Adsorba Hemoperfusion cartridge 101097 | 2018-07-06 |
| Gambro Dialysatoren GmbH | Adsorba Hemoperfusion cartridge 101223 | 2018-03-29 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | Adsorba 300c | 2015-08-27 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | Revaclear | 2013-05-07 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX HEMODIALYZER MODEL 6H | 2008-05-18 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 6LR, 8LR, 10LR | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 6L, 8L, 10L, 14L, 17L, 21L | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 17R, 21R, 24R | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 140H, 170H, 210H | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 11S, 14S, 17S, 21S, 24S | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 6LR, 8LR, 10LR | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 6L, 8L, 10L, 14L, 17L, 21L | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 17R, 21R, 24R | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 140H, 170H, 210H | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 11S, 14S, 17S, 21S, 24S | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 6LR, 8LR, 10LR | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 6L, 8L, 10L, 14L, 17L, 21L | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 17R, 21R, 24R | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 140H, 170H, 210H | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | POLYFLUX 11S, 14S, 17S, 21S, 24S | 2007-03-21 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | ADSORBA | 2006-11-20 |
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.] | ADSORBA 150C | 2006-11-20 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020032336396 | Stadersand,Federal Republic of Germany -> Charleston, South Carolina | TEIL UND ZUBEHOER FUER MASCHINEN DER POS 8444 ODER DEREN HILFSMASCHINEN FLUESSIG KEITSPUMPEN AUCH MIT FLUESSIGKEITSMESSE HEBEWERKE FUER FLUESSIGKEITEN HS CODE 844820 | 1 PKG |
| 2020010655674 | Stadersand,Federal Republic of Germany -> Charleston, South Carolina | PIT STOP EQUIPMENT SPIMA HS-CODE: 844820 | 3 PKG |
| 2019121724368 | Santa Barbara de Samana,Dominican Republic -> San Juan, Puerto Rico | MEDICAL EQUIPT FOR DIALYSIS HTS:84212980 | 208 PKG |
| 2019121319844 | Bremerhaven,Federal Republic of Germany -> Miami, Florida | REVACLEAR 500 HS-CODE: 842129 | 26 PKG |
| 201911026552 | Santa Barbara de Samana,Dominican Republic -> San Juan, Puerto Rico | MEDICAL EQUIPT FOR DIALYSIS HTS: 8421298 | 7392 PKG |
| 2019102133870 | Santa Barbara de Samana,Dominican Republic -> San Juan, Puerto Rico | MEDICAL EQUIPT FOR DIALYSIS HTS: 8421298 | 7392 PKG |
| 201910086483 | Santa Barbara de Samana,Dominican Republic -> San Juan, Puerto Rico | MEDICAL EQUIP FOR DIALYSIS AS PER ORDER NO 3188329 OK/S REVACLEAR 400 HTS: 84212980 | 24 PKG |
| 2019100410324 | Santa Barbara de Samana,Dominican Republic -> San Juan, Puerto Rico | MEDICAL EQUIP FOR DIALYSIS AS PER ORDER NO 3188329 OK/S REVACLEAR 400 HTS: 84212980 | 24 PKG |