Dennis Genito FDA Filings

FDA Registration(s)

Registration Number	3011216300
FEI Number	3011216300
Name	Dennis Genito
Owner & Operator	Tarmetec OU
Contact Address	Ringtee 6 Tartu EE-78 Tartumaa 50105 EE
Official Correspondent	Kalev Nurm 372-7-385011-x
US Agent	Dennis Genito Maquet Cardiovascular 973 7097515 973 8071658 Dennis.genito@Getinge.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	45 Barbour Pond Dr Wayne, NJ 07470 US
Establishment Type	Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number	3003263092
FEI Number	3003263092
Name	Dennis Genito
Owner & Operator	Getinge
Contact Address	Hans-Riedl-Strasse 21 Feldkirchen DE-BY Bayern 85622 DE
Official Correspondent	Dennis Genito 49-89-459914-0
US Agent	Dennis Genito Maquet Cardiovascular 973 7097515 973 8071658 Dennis.genito@Getinge.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	45 Barbour Pond Dr Wayne, NJ 07470 US
Establishment Type	Manufacture Medical Device Repack or Relabel Medical Device

Registration Number	9710055
FEI Number	3002465150
Name	Dennis Genito
Owner & Operator	MAQUET SAS
Contact Address	PARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON, ORLEANS CEDEX 2 FR-NOTA 45074 FR
Official Correspondent	Dennis - Genito 33-238-258732-x
US Agent	Dennis Genito Maquet Cardiovascular 973 7097515 973 8071658 Dennis.genito@Getinge.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	45 Barbour Pond Dr Wayne, NJ 07470 US
Establishment Type	Manufacture Medical Device

FDA Filings

Device Company	Device	Date
KRI Dennis Genito [Tarmetec OU]	SPRINTER CART, SPRINTER CART XL	2019-08-23
FTD Dennis Genito [MAQUET SAS]	Maquet PowerLED II Surgical Light	2019-01-02
FSS Dennis Genito [MAQUET SAS]	Maquet Rolite PowerLED II	2018-11-20
PMN K171620 \| KRB Dennis Genito [Getinge]	PiCCO Catheter	2018-02-22
PMN K172259 \| DXG Dennis Genito [Getinge]	PulsioFlex Monitor	2018-01-25
PMN K172259 \| DXG Dennis Genito [Getinge]	PiCCO Module	2018-01-25
PMN K172259 \| DXG Dennis Genito [Getinge]	CeVOX Module	2018-01-25
PMN K150310 \| ORT Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| NHQ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| NHP Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| NHO Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| MSX Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| MLD Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| MLC Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| MHX Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| LKD Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| KRC Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| KRB Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| KOI Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| KLK Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| GWS Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| FLL Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DXN Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DXG Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DSP Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DSK Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DSJ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DSI Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DSH Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DSF Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DSA Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DRW Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DRT Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DRS Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DRQ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DRJ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DRG Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DQA Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| DPS Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| CCL Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| CCK Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| CBS Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| CBR Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| CBQ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| BZQ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 \| BZC Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K130513 \| FTD Dennis Genito [MAQUET SAS]	VOLISTA ACCESS	2013-08-21
PMN K130513 \| FTD Dennis Genito [MAQUET SAS]	VOLISTA 600	2013-08-21
PMN K130513 \| FTD Dennis Genito [MAQUET SAS]	VOLISTA 400	2013-08-21
PMN K130513 \| FTD Dennis Genito [MAQUET SAS]	TRIOP VOLISTA	2013-08-21
PMN K130513 \| FTD Dennis Genito [MAQUET SAS]	STANDOP VOLISTA	2013-08-21
PMN K130513 \| FTD Dennis Genito [MAQUET SAS]	ROLITE VOLISTA ACCESS	2013-08-21
PMN K130513 \| FTD Dennis Genito [MAQUET SAS]	ROLITE FOR VOLISTA STANDOP	2013-08-21
PMN K130513 \| FSY Dennis Genito [MAQUET SAS]	VOLISTA ACCESS	2013-08-21
PMN K130513 \| FSY Dennis Genito [MAQUET SAS]	VOLISTA 600	2013-08-21
PMN K130513 \| FSY Dennis Genito [MAQUET SAS]	VOLISTA 400	2013-08-21
PMN K130513 \| FSY Dennis Genito [MAQUET SAS]	TRIOP VOLISTA	2013-08-21
PMN K130513 \| FSY Dennis Genito [MAQUET SAS]	STANDOP VOLISTA	2013-08-21
PMN K130513 \| FSY Dennis Genito [MAQUET SAS]	ROLITE VOLISTA ACCESS	2013-08-21
PMN K130513 \| FSY Dennis Genito [MAQUET SAS]	ROLITE FOR VOLISTA STANDOP	2013-08-21
PMN K122121 \| DXG Dennis Genito [Getinge]	Pulsioflex	2012-12-31
PMN K122121 \| DXG Dennis Genito [Getinge]	Pulsioflex Monitoring System	2012-12-31
PMN K122121 \| DXG Dennis Genito [Getinge]	Pulsioflex Monitoring System with PiCCO Module	2012-12-31
PMN K122121 \| DXG Dennis Genito [Getinge]	PC4510	2012-12-31
PMN K122121 \| DXG Dennis Genito [Getinge]	PC4000	2012-12-31
PMN K113679 \| NTN Dennis Genito [MAQUET SAS]	LUCEA LED	2012-01-20
PMN K113679 \| NTN Dennis Genito [MAQUET SAS]	LUCEA 50	2012-01-20
PMN K113679 \| NTN Dennis Genito [MAQUET SAS]	LUCEA 100	2012-01-20
PMN K113679 \| FTD Dennis Genito [MAQUET SAS]	LUCEA LED	2012-01-20
PMN K113679 \| FTD Dennis Genito [MAQUET SAS]	LUCEA 50	2012-01-20
PMN K113679 \| FTD Dennis Genito [MAQUET SAS]	LUCEA 100	2012-01-20
PMN K113679 \| FSS Dennis Genito [MAQUET SAS]	LUCEA LED	2012-01-20
PMN K113679 \| FSS Dennis Genito [MAQUET SAS]	LUCEA 50	2012-01-20
PMN K113679 \| FSS Dennis Genito [MAQUET SAS]	LUCEA 100	2012-01-20
PMN K112448 \| DXG Dennis Genito [Getinge]	Pulsioflex	2011-12-15
PMN K091786 \| DXG Dennis Genito [Getinge]	PiCCO2 (8500), CEVOX OPTICAL MODULE (PC3015) AND ACCESSORIES	2011-08-23
PMN K780126 \| DRE Dennis Genito [Getinge]	PiCCO Arterial Catheter Procedure K	2010-04-05
KZF Dennis Genito [MAQUET SAS]	POWERLED 300	2009-12-15
KZF Dennis Genito [MAQUET SAS]	LUCEA LED	2009-12-15
KZF Dennis Genito [MAQUET SAS]	LUCEA 40	2009-12-15
KZF Dennis Genito [MAQUET SAS]	LUCEA 10	2009-12-15
FXR Dennis Genito [MAQUET SAS]	SATELITE MEDIA HD	2009-11-09
KQM Dennis Genito [MAQUET SAS]	ORCHIS	2008-11-14
KQM Dennis Genito [MAQUET SAS]	ORCHIDE	2008-11-14
KQM Dennis Genito [MAQUET SAS]	ORCHIDE 3D	2008-11-14
PMN K982063 \| FSY Dennis Genito [MAQUET SAS]	PRISMALIX	2008-03-05
PMN K970886 \| FSS Dennis Genito [MAQUET SAS]	Hanaulux Blue 80 Hosp	2008-03-05
PMN K954169 \| FSY Dennis Genito [MAQUET SAS]	Hanaulux Blue 30 80	2008-03-05
PMN K954169 \| FSS Dennis Genito [MAQUET SAS]	Hanaulux Blue 30 80	2008-03-05
PMN K932451 \| FTD Dennis Genito [MAQUET SAS]	Hanalux 2005	2008-03-05
PMN K895715 \| FTD Dennis Genito [MAQUET SAS]	Hanaulux 2000	2008-03-05
PMN K070442 \| FSY Dennis Genito [MAQUET SAS]	Rolite PowerLED	2008-03-05
PMN K070442 \| FSY Dennis Genito [MAQUET SAS]	PowerLED 700	2008-03-05
PMN K070442 \| FSY Dennis Genito [MAQUET SAS]	PowerLED 500	2008-03-05
PMN K070442 \| FSY Dennis Genito [MAQUET SAS]	PowerLED 300	2008-03-05
PMN K070442 \| FSY Dennis Genito [MAQUET SAS]	POWERLED	2008-03-05
PMN K040735 \| FSY Dennis Genito [MAQUET SAS]	X'TEN (X10)	2008-03-05
PMN K040015 \| FSY Dennis Genito [MAQUET SAS]	PRISMALIX w/ ENERGIX	2008-03-05
PMN K030906 \| FSY Dennis Genito [MAQUET SAS]	AXCEL	2008-03-05
PMN K991886 \| KRB Dennis Genito [Getinge]	Pulsion Pulsiocath	2007-12-06
PMN K991886 \| KRB Dennis Genito [Getinge]	Pulsion Pulsiocath, PiCCO Monitorin	2007-12-06
PMN K991886 \| KRB Dennis Genito [Getinge]	Pulsion PCCO Monitoring Kit (PV8103, PV8115, PV8115CVP)	2007-12-06
PMN K072735 \| DXG Dennis Genito [Getinge]	Pulsion PiCCO-2, Model 8500	2007-12-06
PMN K072364 \| KRB Dennis Genito [Getinge]	Pulsiocath Thermodilution Catheters	2007-12-06
PMN K060898 \| DXG Dennis Genito [Getinge]	Pulsion PiCCO Plus, Model 8100	2007-12-06
PMN K020587 \| KRB Dennis Genito [Getinge]	Injectate Sensor Temperature Housing PV4046	2007-12-06
PMN K001762 \| DXG Dennis Genito [Getinge]	Continuous Pulse Contour Cardiac	2007-12-06