Denise Oppermann

FDA Filings

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

FDA Registration(s)
Registration Number8030665
FEI Number3002807744
NameDenise Oppermann
Owner & OperatorFresenius Medical Care North America
Contact Address920 WINTER STREET --
Waltham MA 02451 US
Official Correspondent
  • DENISE OPPERMANN
  • x-781-6994479-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address920 Winter St.
Waltham, MA 02451 US
Establishment TypeManufacture Medical Device



Registration Number9616074
FEI Number3002654698
NameDenise Oppermann
Owner & OperatorFresenius Medical Care Holdings, Inc.
Contact Address920 Winter Street
Waltham MA 02451 US
Official Correspondent
  • Denise Oppermann
  • 01-781-6994479-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address920 Winter Street
North Waltham, MA 02451 US
Establishment TypeManufacture Medical Device



Registration Number9611823
FEI Number3002807005
NameDenise Oppermann
Owner & OperatorFRESENIUS MEDICAL CARE
Contact AddressELSE KROENER-STRASSE 1 --
BAD HOMBURG DE-HE Hessen D-61352 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address920 Winter Street
Waltham, MA 02451 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number9616277
FEI Number3003244997
NameDENISE OPPERMANN
Owner & OperatorFRESENIUS MEDICAL CARE
Contact AddressELSE KROENER-STRASSE 1 --
BAD HOMBURG DE-HE Hessen D-61352 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address920 Winter St
North Waltham, MA 02451 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Denise Oppermann [Fresenius Medical Care Holdings, Inc.]
NX Stage Cartridge with Infusion Line2019-10-23
Denise Oppermann [Fresenius Medical Care Holdings, Inc.]
ViraGuard Viral Blocking Patient Transducer Protector2019-09-25
Denise Oppermann [Fresenius Medical Care Holdings, Inc.]
NxStage Cartridge Express2019-09-25
DENISE OPPERMANN [FRESENIUS MEDICAL CARE]
bibag2018-06-28
Denise Oppermann [Fresenius Medical Care North America]
StaySafe to Luer-Lock Adapater2018-05-24
Denise Oppermann [Fresenius Medical Care North America]
StaySafe Catheter Ext Set with Safe-Lock, 122018-05-24
Denise Oppermann [Fresenius Medical Care North America]
StaySafe Catheter Ext Set with Luer-Lock, 62018-05-24
Denise Oppermann [Fresenius Medical Care North America]
StaySafe Catheter Ext Set with Luer-Lock, 182018-05-24
Denise Oppermann [Fresenius Medical Care North America]
StaySafe Catheter Ext Set with Luer-Lock, 122018-05-24
Denise Oppermann [Fresenius Medical Care North America]
Dialyzer holder lock sleeve2018-05-17
Denise Oppermann [Fresenius Medical Care North America]
StaySafe Organizer2018-05-15
Denise Oppermann [Fresenius Medical Care North America]
StaySafe Organizer Holder2018-05-15
Denise Oppermann [Fresenius Medical Care North America]
StaySafe Handi-Tool2018-05-15
Denise Oppermann [Fresenius Medical Care North America]
StaySafe Clip2018-05-15
Denise Oppermann [Fresenius Medical Care North America]
Liberty Cycler Set2018-05-15
Denise Oppermann [Fresenius Medical Care North America]
stay safe Drain Set2018-02-15
Denise Oppermann [Fresenius Medical Care North America]
Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors2018-02-15
Denise Oppermann [Fresenius Medical Care North America]
Cycler Drain Bag Set2018-01-26
Denise Oppermann [Fresenius Medical Care North America]
CAREline Airless Hemodialysis Blood Tubing Sets2017-12-19
Denise Oppermann [Fresenius Medical Care North America]
CAREline Airless Hemodialysis Blood Tubing Sets2017-12-19
Denise Oppermann [FRESENIUS MEDICAL CARE]
Fresenius Sterile Stay Safe Cap2017-03-28
Denise Oppermann [Fresenius Medical Care North America]
Combiset Blood Line2017-02-17
Denise Oppermann [Fresenius Medical Care North America]
PD Cycler Set with 2 Triggers2017-02-17
Denise Oppermann [Fresenius Medical Care North America]
PD Cycler Set with 1 Trigger2017-02-17
Denise Oppermann [Fresenius Medical Care North America]
Crit-Line Clip (CLiC) Blood Chamber2016-01-26
Denise Oppermann [Fresenius Medical Care North America]
APD Luer Lock Adapter2015-02-27
Denise Oppermann [Fresenius Medical Care North America]
Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set2012-06-27
Denise Oppermann [Fresenius Medical Care North America]
2008K@HOME HEMODIALYSIS MACHINE2011-05-04
Denise Oppermann [Fresenius Medical Care North America]
2008K@HOME HEMODIALYSIS MACHINE2011-05-04
Denise Oppermann [Fresenius Medical Care North America]
LIBERTY DRAIN LINE LUER TAPE2009-07-16
Denise Oppermann [Fresenius Medical Care North America]
Safe-Lock catheter adapter Co-Pack II2009-07-16
Denise Oppermann [Fresenius Medical Care North America]
CATHETER ADAPTER SEALING CAP2009-07-16
Denise Oppermann [Fresenius Medical Care North America]
Universal connector2009-07-16
Denise Oppermann [Fresenius Medical Care North America]
4 LEAD ECO PREFILLED W/SNAP DISCONNECT2009-07-16
Denise Oppermann [Fresenius Medical Care North America]
Fresenius Sterile Stay Safe Cap2008-12-30
Denise Oppermann [Fresenius Medical Care North America]
Fresenius PD+ IQ Card Cycler2008-03-18
Denise Oppermann [Fresenius Medical Care North America]
Combilines Hemodialysis Blood Tubing Set2008-03-05
Denise Oppermann [Fresenius Medical Care North America]
CAPD SAFE LOCK TRANSFER SET, STAY SAFE DRAIN SET2008-01-08
Denise Oppermann [Fresenius Medical Care North America]
Split Septum Injection Sites2008-01-08
Denise Oppermann [Fresenius Medical Care North America]
Fresenius Standalone Access Flow Reserving Connector2008-01-08
Denise Oppermann [Fresenius Medical Care North America]
CAPD Staysafe Disposable Adminstration Sets with Staysafe Connector2008-01-08
Denise Oppermann [Fresenius Medical Care North America]
Fresenius Priming Set with Needless Access Port2008-01-08
Denise Oppermann [Fresenius Medical Care North America]
Transducer Protectors2008-01-08
Denise Oppermann [Fresenius Medical Care North America]
Fresenius Bloodlines Patient Connector (HemaClip)2008-01-08
Denise Oppermann [Fresenius Medical Care North America]
Fresenius Combilines Blood Tubing Set2008-01-08
Denise Oppermann [Fresenius Medical Care North America]
Fresenius Combilines Single Needle Blood Tubing Set2008-01-08

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