Gambro Dasco S P A

FDA Filings

This page includes the latest FDA filings for Gambro Dasco S P A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9616240
• FEI Number: 3002807196
• Name: GAMBRO DASCO S.P.A.
• Owner & Operator: Gambro Renal Products, Inc.
• Contact Address: One Baxter Parkway ; Deerfield IL 60015 US
• Official Correspondent:
  • Thomas P Sampogna
  • 1-224-9483016-x
• US Agent:
  • Thomas Sampogna
  • Baxter Healthcare Corporation
  • 224 9483016
  • 224 2704119
  • thomas_sampogna@baxter.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: VIA MODENESE,66 ; MEDOLLA Modena, 41036 IT
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 37332414121595 GAMBRO DASCO SPA	NA - NA 115959	2025-02-07
GUDID 37332414075829 GAMBRO DASCO SPA	107650 107650	2021-08-09
GUDID 37332414075430 GAMBRO DASCO SPA	107620 107620	2019-06-07
GUDID 37332414048915 GAMBRO DASCO SPA	105762 105762	2019-06-07
GUDID 37332414044733 GAMBRO DASCO SPA	105551 105551	2019-06-07
GUDID 37332414032532 GAMBRO DASCO SPA	102074 102074	2019-06-07
GUDID 37332414010868 GAMBRO DASCO SPA	101593 101593	2019-06-07
GUDID 37332414004690 GAMBRO DASCO SPA	101354 101354	2019-06-07
GUDID 07332414106126 GAMBRO DASCO SPA	EXALIS 113297	2018-12-17
GUDID 07332414106119 GAMBRO DASCO SPA	EXALIS 6041909	2018-12-17
GUDID 07332414042035 GAMBRO DASCO SPA	PHOENIX 103453	2018-07-06
PMN K131516 | KDI GAMBRO DASCO S.P.A. [Gambro Renal Products, Inc.]	Prismaflex System 7.10	2014-12-22
PMN K103832 | KDI GAMBRO DASCO S.P.A. [Gambro Renal Products, Inc.]	PHOENIX MONITOR	2011-05-25
PMN K083158 | KDI GAMBRO DASCO S.P.A. [Gambro Renal Products, Inc.]	EXALIS	2009-07-13
PMN K070643 | KDI GAMBRO DASCO S.P.A. [Gambro Renal Products, Inc.]	PHOENIX SYSTEM	2008-05-18

Related Finance Registrations

NCAGE Code	A5309	GAMBRO DASCO SPA
CAGE Code	A5309	GAMBRO DASCO SPA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082633314	La Spezia,Italy -> Miami, Florida	MEDICAL SUPPLIES HS CODE:901890	23 PKG
2020081982571	La Spezia,Italy -> Miami, Florida	PLASTIC GOODS 39041000	80 PKG
2020081982571	La Spezia,Italy -> Miami, Florida	PLASTIC GOODS 39041000	80 PKG
2020081982571	La Spezia,Italy -> Miami, Florida	PLASTIC GOODS 39041000	80 PKG
2020081982571	La Spezia,Italy -> Miami, Florida	PLASTIC GOODS 39041000	80 PKG
2020080577342	Manzanillo,Mexico -> Los Angeles, California	POLYMERS OF VINYL CHLORIDE OR OF OTHER HALOGE NATED - PLASTIC GOODS 39041000	100 PKG
2020080577342	Manzanillo,Mexico -> Los Angeles, California	POLYMERS OF VINYL CHLORIDE OR OF OTHER HALOGE NATED - PLASTIC GOODS 39041000	100 PKG
2020080577342	Manzanillo,Mexico -> Los Angeles, California	POLYMERS OF VINYL CHLORIDE OR OF OTHER HALOGE NATED - PLASTIC GOODS 39041000	100 PKG
2020080577342	Manzanillo,Mexico -> Los Angeles, California	POLYMERS OF VINYL CHLORIDE OR OF OTHER HALOGE NATED - PLASTIC GOODS 39041000	100 PKG
2020080577342	Manzanillo,Mexico -> Los Angeles, California	POLYMERS OF VINYL CHLORIDE OR OF OTHER HALOGE NATED - PLASTIC GOODS 39041000	100 PKG
2020070836547	La Spezia,Italy -> Miami, Florida	MEDICAL SUPPLIES HS CODE:901890	48 PKG
2020070836547	La Spezia,Italy -> Miami, Florida	MEDICAL SUPPLIES HS CODE:901890	48 PKG
2020062528425	La Spezia,Italy -> Miami, Florida	MEDICAL SUPPLIES HS CODE:901890	24 PKG
2020060215214	La Spezia,Italy -> Miami, Florida	MEDICAL SUPPLIES HS CODE:901890	24 PKG
2020052514777	La Spezia,Italy -> Miami, Florida	MEDICAL SUPPLIES HS:300490	1480 PKG
2020050110080	La Spezia,Italy -> Miami, Florida	MEDICAL SUPPLIES HS:901890	343 PKG