Pre Holding Inc

FDA Filings

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

Pre Holding Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number2954963
FEI Number1000142942
NamePARI RESPIRATORY EQUIPMENT, INC.
Owner & OperatorPRE HOLDING, INC.
Contact Address2412 PARI Way --
Midlothian VA 23112 US
Official Correspondent
  • MICHAEL N JUDGE
  • x-804-2537274-269
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2412 PARI Way
MIDLOTHIAN, VA 23112 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only



Registration Number3003767629
FEI Number3003767629
NameMICHAEL JUDGE
Owner & OperatorPRE HOLDING, INC.
Contact Address2412 PARI Way --
Midlothian VA 23112 US
Official Correspondent
  • MICHAEL N JUDGE
  • x-804-2537274-269
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2412 PARI Way
MIDLOTHIAN, VA 23112 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Owner/Operator Registration


FDA Filings

Device
Company
DeviceDate
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
TRIAL FRAME2020-01-06
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
NASAL SHOWER2020-01-06
MICHAEL JUDGE [PRE HOLDING, INC.]
TRIAL FRAME2020-01-06
MICHAEL JUDGE [PRE HOLDING, INC.]
NASAL SHOWER2020-01-06
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Zirela Nebulizer System2019-06-06
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Magnair Nebulizer System2017-12-21
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Lamira Nebulizer System2017-12-21
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
O-PEP2017-05-31
MICHAEL JUDGE [PRE HOLDING, INC.]
O-PEP2017-05-31
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
PARI Baby Nebulizer2015-12-14
MICHAEL JUDGE [PRE HOLDING, INC.]
PARI Baby Nebulizer2015-12-14
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Filter/Valve Set2015-12-14
MICHAEL JUDGE [PRE HOLDING, INC.]
Filter/Valve Set2015-12-14
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
LC Plus2013-01-15
MICHAEL JUDGE [PRE HOLDING, INC.]
LC Plus2013-01-15
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
PEP S2013-01-15
MICHAEL JUDGE [PRE HOLDING, INC.]
PEP S2013-01-15
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Hyper-Sal2013-01-15
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
SinuStar2013-01-15
MICHAEL JUDGE [PRE HOLDING, INC.]
SinuStar2013-01-15
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
ERAPID2012-07-30
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
LC Disposable2012-03-13
MICHAEL JUDGE [PRE HOLDING, INC.]
LC Disposable2012-03-13
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Peak Flow Meter2012-01-11
MICHAEL JUDGE [PRE HOLDING, INC.]
Peak Flow Meter2012-01-11
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Altera2011-12-22
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Vios2011-12-22
MICHAEL JUDGE [PRE HOLDING, INC.]
Vios2011-12-22
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
PARI Sinus2011-12-22
MICHAEL JUDGE [PRE HOLDING, INC.]
PARI Sinus2011-12-22
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Trio2009-02-20
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
LC Sprint2007-11-29
MICHAEL JUDGE [PRE HOLDING, INC.]
LC Sprint2007-11-29
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
LC Sprint2007-11-29
MICHAEL JUDGE [PRE HOLDING, INC.]
LC Sprint2007-11-29
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Trek S2007-11-29
MICHAEL JUDGE [PRE HOLDING, INC.]
Trek S2007-11-29
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Vortex2007-11-29
MICHAEL JUDGE [PRE HOLDING, INC.]
Vortex2007-11-29
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
TRIAL FRAME2006-09-27
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
NASAL SHOWER2006-09-27
MICHAEL JUDGE [PRE HOLDING, INC.]
TRIAL FRAME2006-09-27
MICHAEL JUDGE [PRE HOLDING, INC.]
NASAL SHOWER2006-09-27
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
PARI PEP2006-09-15
MICHAEL JUDGE [PRE HOLDING, INC.]
PARI PEP2006-09-15
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
WING TIP TUBING2006-09-15
MICHAEL JUDGE [PRE HOLDING, INC.]
WING TIP TUBING2006-09-15
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Vios Pro2005-09-28
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Proneb Ultra2005-09-28
MICHAEL JUDGE [PRE HOLDING, INC.]
Vios Pro2005-09-28
MICHAEL JUDGE [PRE HOLDING, INC.]
Proneb Ultra2005-09-28
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
Bubbles the Fish2005-03-07
MICHAEL JUDGE [PRE HOLDING, INC.]
Bubbles the Fish2005-03-07
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
DURA-NEB1997-07-10
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
PARI Baby Mask1997-07-10
PARI RESPIRATORY EQUIPMENT, INC. [PRE HOLDING, INC.]
PARI Adult Mask1997-07-10
MICHAEL JUDGE [PRE HOLDING, INC.]
PARI Baby Mask1997-07-10
MICHAEL JUDGE [PRE HOLDING, INC.]
PARI Adult Mask1997-07-10

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