Gambro Industries

FDA Filings

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

FDA Registration(s)
Registration Number8010182
FEI Number3002807204
NameGAMBRO INDUSTRIES
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7, AV. LIONEL TERRAY, B.P. 126
MEYZIEU CEDEX Rhone, 69883 FR
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
GAMBRO INDUSTRIES
 PRISMAFLEX SET 107643US2022-11-30
GAMBRO INDUSTRIES
 PRISMAFLEX SET 107636US2022-11-30
GAMBRO INDUSTRIES
 PRISMAFLEX SET 107640US2022-11-30
GAMBRO INDUSTRIES
 PRISMAFLEX SET 1099902020-02-13
GAMBRO INDUSTRIES
 PRISMAFLEX SET 1071422020-02-13
GAMBRO INDUSTRIES
 PRISMAFLEX SET 1066972020-02-13
GAMBRO INDUSTRIES
 PRISMAFLEX SET 1066962020-02-13
GAMBRO INDUSTRIES
 PRISMAFLEX TPE 2000 SET 1140932020-02-13
GAMBRO INDUSTRIES
 PRISMAFLEX SET 1071402020-01-30
GAMBRO INDUSTRIES
 DIACLEAR 1068872018-07-06
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
DIACLEAR2010-02-16
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX M150 SET2008-10-07
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX HF 1400 SET2008-05-18
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX HF 1000 SET2008-05-18
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX TPE 2000 SET2006-11-22
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMA TPE 2000 SET2006-11-22
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX MONITOR2006-04-06
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX M60 SET2006-04-06
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX M100 SET2006-04-06

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019081913742Le Havre,France -> Los Angeles, California20 PALLET FILTER DIALYSIS INV 9196405240 PCL
201901127205Le Havre,France -> Los Angeles, California33 PARCEL PART OF FILTER DIALYSIS LOADED ON 23 PALLET693 CAS
201901127205Le Havre,France -> Los Angeles, California46 BOXES PART OF FILTER DIALYSIS LOADED ON 23 BOXPALETT693 CAS
201901127205Le Havre,France -> Los Angeles, California614 PARCELS PART OF FILTER DIALYSIS LOADED ON 26 PALLET693 CAS
2018081634347FOS Sur Mer,France -> Savannah, Georgia962 PACKAGES FILTER DIALYSIS LOADED ON 24 PALLETS PROFORMA P180722/P180176 DELIVERY NOTE: MT07202018 TEMPORARY EXPORTATION962 PCK
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