Gambro Rostock G M B H

FDA Filings

This page includes the latest FDA filings for Gambro Rostock G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007697864
• FEI Number: 3007697864
• Name: Gambro Rostock GmbH
• 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
  • 224 9483016
  • 224 2704119
  • thomas_sampogna@baxter.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Friedrich Barnewitz-Str.3 ; Rostock Mecklenburg-Vorpommern, 18119 DE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K133807 | KDI Gambro Rostock GmbH [Gambro Renal Products, Inc.]	XMARS	2014-06-18
PMN K133807 | KDI Gambro Rostock GmbH [Gambro Renal Products, Inc.]	Prismaflex System	2014-06-18
PMN K133807 | FLD Gambro Rostock GmbH [Gambro Renal Products, Inc.]	XMARS	2014-06-18
PMN K133807 | FLD Gambro Rostock GmbH [Gambro Renal Products, Inc.]	Prismaflex System	2014-06-18
PMN K113313 | FLD Gambro Rostock GmbH [Gambro Renal Products, Inc.]	Molecular Adsorbent Recirculating System (MARS)	2012-12-17