Providien Device Assembly L L C

FDA Filings

This page includes the latest FDA filings for Providien Device Assembly L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3009746061
FEI Number3009746061
NameIntegra Biotechnical, SA de CV
Owner & OperatorProvidien Device Assembly, LLC.
Contact Address2731 Loker Ave West
Carlsbad CA 92010 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressFerrocarril # 17030 Interior 3, 4, 8, 16 & 17 Col. Ninos Heroes Este
Tijuana Baja California, 22120 MX
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



Registration Number2030116
FEI Number1000519289
NamePROVIDIEN DEVICE ASSEMBLY, LLC
Owner & OperatorProvidien Device Assembly, LLC.
Contact Address2731 Loker Ave West
Carlsbad CA 92010 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2731 Loker Ave W
Carlsbad, CA 92010 US



FDA Filings

Device
Company
DeviceDate
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Waste Management Accessory2020-03-12
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Waste Bag, 6L2020-03-12
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Tissue Catch with Suction Tubing2020-03-12
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Fluid Management Accessory2020-03-12
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
NovoTTF 100L System2020-01-30
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Soft K-Bride; Soft K-Rette2019-03-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
ambIT Uni-Flo Fenestrated Catheter2017-11-30
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
ambIT PreSet Pump2017-11-17
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
ambIT PreSet PCA Pump2017-11-15
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
ambIT PreSet PCA Pump2017-11-15
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Histologics SoftBiopsy Tissue Collection and Transport System2017-11-15
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
SafeStep Huber Needle Set2017-11-09
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
PowerLoc MAX Power Injectable Infusion Set2017-11-09
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Z-Slider2017-09-13
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
POWERWAND Safety Introducer with an Extended Dwell Catheter, 3 Fr. Model2017-05-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
POWERWAND XL 5Fr 8cm Extended Dwell Catheter2017-05-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
POWERWAND XL 5Fr 10cm Extended Dwell Catheter2017-05-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
POWERWAND XL 4Fr 8cm Extended Dwell Catheter2017-05-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
POWERWAND XL 4Fr 10cm Extended Dwell Catheter2017-05-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
5 Fr 8cm POWERWAND Safety Introducer with Extended Dwell Catheter2017-05-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
5 Fr 10cm POWERWAND Safety Introducer with Extended Dwell Catheter2017-05-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
4 Fr 8cm POWERWAND Safety Introducer with Extended Dwell Catheter2017-05-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
4 Fr 10cm POWERWAND Safety Introducer with Extended Dwell Catheter2017-05-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Thermal Angel Blood/Fluid Warmer2016-08-25
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Thermal Angel Blood/Fluid Warmer2016-08-25
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Fenestrated Catheters (Ambit Tunnerler)2014-09-25
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Scalpel disarmer2014-09-02
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Ventana Medical Pouch subassembly2014-05-28
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
InflammaDry2013-12-30
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
InflammaDry2013-12-30
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
PowerLoc Max Safety Infusion Set2013-12-30
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
PowerLoc Safety Infusion Set2013-12-30
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
PowerLoc Safety Infusion Set2013-12-30
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Miniloc Safety Infusion sets2013-12-19
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Arthoscopic CAnnula (2.5 MM & 4.5 MM)2013-09-10
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
FMS DUO tubing assemblies2013-08-29
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
FMS VUO Tubing assemblies2013-08-29
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
T Ring Digit tourniquet, T Ring Toe Tourniquet2013-08-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
RPS Adeno Detector, Catalogs: RPS-AD, RPS-DE, FSC-AD, NIC-AD2013-05-31
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Monojet Bone Marrow Biopsy2013-04-24
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Performa Catheters2013-01-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
FAS Lines (Merit)2013-01-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
CT Transfer and related subassemblies (Merit)2013-01-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Perfic Cath (Adapta)2013-01-22
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
ZTUBG0762012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
ZTUBG-0752012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
SA03000152012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
RE75172012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
R87742012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
R87722012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
R87312012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
R87042012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Part Numbers2012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BXPU8362012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BXPU8242012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BXPU8162012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BXPU6362012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BXPU6242012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BXPU6162012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BXPU5362012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BXPU5242012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BXPU5162012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BXPU4242012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BXPU4162012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
3901-10202012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
31042012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
200795-0012012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
200684-0012012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
200603-0012012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
20-1620-122012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
20-1615-10F2012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
20-1615-102012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
20-1520-18L2012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
20-1520-182012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
20-1500-242012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
20-1500-182012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
20-1500-122012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
20-1500-092012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
10255692012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
10199742012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
10-15502012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
10-1550-0012012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
010-0622012-11-21
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
MoBio Tube & Spin Filter2012-10-12
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Los Alamos Retractable Knife2012-09-17
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Futura Safety Scalpel2012-09-17
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Tubing, Polyethylene2012-09-17
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
J Tube2012-09-17
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Hook Tube2012-09-17
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Fill Tube -720-000-00012012-09-17
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Texium Syringe2012-09-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Part numbers: MY8003, MY8005, MY8010, MY8020, MY8030, MY8060, MY8003-0006, MY8005-0006, MY8010-0006,2012-09-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
MY8020-0006, MY8030-0006 & MY8060-00062012-09-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Ventilator, Emergency, Powered (resuscitator)2012-09-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Ventilator, Emergency, Powered (resuscitator)2012-09-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
NOVOCURE NOVOTTF-100A SYSTEM2012-08-09
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Disposable electrodes (Part NOV 022/NOV 024)2012-08-09
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BioPointe Pipette Tips2012-08-01
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
BioPointe Bulk Pipette Tips2012-08-01
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Soft Endo Cervical Curette2012-04-19
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Histologics Soft-ECC2012-04-19
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Huber Needle infusion set2012-03-15
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Time Out Scalpel Handle2012-03-15
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Sandel Safety Scalpel2012-03-15
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
International Health Products Baker Jejunostomy Tube2012-03-13
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
IHP Baker Jejunostomy Catheter2012-03-13
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Baker Intestinal Tube2012-03-13
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Specimen Container2012-01-30
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Ansell Sandel Specimen Bowl2012-01-30
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Z-Universal Holder2012-01-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Z-Tray2012-01-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Z-Suture Bag2012-01-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Z-Scope Holder2012-01-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Z-Friction Drape2012-01-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Z-Cord and Tube Holder2012-01-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Specimen Bowl2012-01-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Change-A-Blade2012-01-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Blade Disarmer2012-01-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Summit Medical Ambulatory Infusion Pump2011-11-29
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
AMBIT Push & Play2011-11-29
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Time Out Marker2011-11-10
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Sandel Safety Marker2011-11-10
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Specimen Handling System2011-09-12
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Medication Labels-Sandel2011-09-12
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Correct Medication Labeling System2011-09-12
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Ansell Sandel Medical Solutions LLC2011-09-12
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Tube Sets2011-03-25
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Filter2011-03-24
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Creative Biotech Flow Meter2011-03-24
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Vascular Pathways Introducer2011-03-24
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Autosafe-Reflex Safety Huber Infusion Set2011-03-18
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Autosafe Advantage Safety Huber Infusion Set2011-03-18
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Autosafe-Reflex Safety Huber Infusion Set2011-03-18
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Autosafe Advantage Safety Huber Infusion Set2011-03-18
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
DirectFlow2011-01-28
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
SwiftGrip2010-06-04
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Cardiopulmonary Bypass Blood Reserv2009-05-11
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Merit Medical Systems, Inc. FAS2009-05-11
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Fluid Administration Set2009-05-11
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Merit Disposal Depot2009-05-11
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
CPAP2009-05-11
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
CPAP Breathing Circuit and Mask2009-05-11
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Miser Contrast Management2009-05-11
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Merit Disposal Depot (BAG)2009-05-11
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
IV Bag2009-05-11
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
The Wand Micro Access Safety Introd2009-05-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Aplicare Dressing Change Kit2009-04-20
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Aplicare Convenience Kits2009-04-20
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
PowerLoc Safety Huber2008-10-17
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
AMBIT Continuous Ambulatory Infusio2008-10-17
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Pressure Infusor Bag (PIB)2008-10-15
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Sandel Safety SCALPEL2008-07-25
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
MDD2007-12-08
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
FAS2007-12-08
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
CT Sets2007-12-08
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
EntraCare2007-10-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
Huber Plus2007-10-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
PowerLoc Safety Infusion Set2007-10-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
MiniLoc Safety Infusion Set2007-10-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
LiftLoc Safety Infusion Set2007-10-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
FACE-IT SHIELD2005-10-12
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
MAXITHERM2005-10-12
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
WIN SHEILD2005-10-05
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
STABLTRACH2005-03-30
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
GEL MATRIX2003-06-30
Integra Biotechnical, SA de CV [Providien Device Assembly, LLC.]
HOPE NEBULIZER2003-06-30

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