Nulibry
fosdenopterin hydrobromide
SENT
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012409105 | 3012409105 | SENTEC, INC. | 1 | Y | 2026-01-01 | 40 Albion Road Suite 100 Lincoln RI US 02865 |
| 3014683063 | 3014683063 | SENTECH USA INC | 1 | Y | 2026-01-01 | 19700 S.Vermont Ave. STE 200 Torrance CA US 90502 |
| 3014937935 | 3014937935 | SENTECH GMI Corp | 1 | N | 2026-01-01 | #1713~1714, 416, Hwagok-ro, Gangseo-gu Seoul KR 07548 |
| 3017435704 | 3017435704 | SENTIAR, INC. | 1 | N | 2026-01-01 | 212 N Kingshighway Blvd Suite 115, Box 28 Saint Louis MO US 63108 |
| 3021468326 | 3021468326 | SENTINEL MEDICAL TECHNOLOGIES, LLC | 1 | Y | 2026-01-01 | 50 N Laura St Ste 2500 Jacksonville FL US 32202 |
| 3039524192 | 3039524192 | SENTINEL MOUTHGUARDS | 1 | N | 2026-01-01 | 400 83rd Ave N Saint Petersburg FL US 33702 |
| 3005802238 | 3006482885 | SENTREHEART INC. | 1 | N | 2020-04-25 | 300 Saginaw Dr Redwood City CA US 94063 |
| 3011580969 | 3011580969 | SENTIENX SDN BHD | 1 | N | 2020-04-25 | Lot 7, Jalan Hi-Tech 12, Zon Industri Fasa 3, Kulim Hi-Tech Park Kulim Kedah MY 09090 |
| 3013836104 | 3013836104 | SENTIENT LASERS, LLC | 1 | Y | 2020-04-25 | 4383 N Forestdale Dr. Park City UT US 84098 |
| 3013859902 | 3013859902 | SENTIRE MED LLC | 1 | Y | 2020-04-25 | 10 Schalks Crossing Road Suite 501-125 Plainsboro NJ US 08536 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 300651 | 1606086597 | K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | EZL | 2024-04-17 |
| 279136 | 1882759878 | K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) | LLZ | 2023-07-14 |
| 300651 | 1817582263 | K210570 | TraumaGuard Intra-abdominal Pressure Sensing System | PHU | 2021-10-29 |
| 279136 | 1785679361 | K192890 | SentEP | LLZ | 2020-09-18 |
| 186073 | 1918114770 | K173386 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs | KGO | 2018-04-09 |
| 186073 | 1318596263 | K173304 | Finessis Intense Polyisoprene Surgical Glove | KGO | 2018-04-30 |
| 186073 | 1011374049 | K171987 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove | KGO | 2017-10-20 |
| 216004 | 1453599533 | K163204 | A08 Power wheelchair | ITI | 2017-05-05 |
| 186073 | 1408247926 | K162852 | Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove | KGO | 2017-02-08 |
| 186073 | 1770068311 | K153510 | Powder Free Polychloroprene Examination Glove Green | LZA | 2016-03-21 |
| 235039 | 1234687945 | K153096 | LARIAT RS Suture Delivery Device | GAT | 2015-11-25 |
| 186073 | 1122035458 | K151607 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove | KGO | 2015-11-16 |
| 186073 | 1275660013 | K151605 | Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves | KGO | 2015-11-16 |
| 195076 | 1506145158 | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet | LKD | 2015-12-17 |
| 186073 | 1774912980 | K150973 | NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs | KGO | 2015-08-04 |
| 235039 | 1428898645 | K142241 | LARIAT sulture Delivery Device | GAT | 2014-09-12 |
| 186073 | 1427915706 | K140355 | SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM | KGO | 2014-11-06 |
| 186073 | 1616937618 | K131751 | FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES | KGO | 2013-09-25 |
| 186073 | 1379465008 | K123629 | FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES | KGO | 2013-05-13 |
| 186073 | 1275761603 | K123628 | STERILE LATEX SURGICAL GLOVE | KGO | 2013-03-18 |
| 186073 | 1963917298 | K121335 | G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE | KGO | 2012-09-13 |
| 186073 | 1382438948 | K110698 | NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE | KGO | 2011-12-07 |
| 186073 | 1899506445 | K102119 | SUR-G GLOV AND MAXITEX | KGO | 2010-08-27 |
| 235039 | 2055779782 | K090385 | LARIAT II SUTURE DELIVERY DEVICE | GAT | 2009-05-06 |
| 235039 | 1544752783 | K080364 | FINDRWIRZ GUIDE WIRE SYSTEM | DQX | 2008-08-11 |
| 235039 | 1738849252 | K070126 | OCCLUSION BALLOON CATHETER | DQY | 2008-02-08 |
| 186073 | 1340108865 | K041437 | MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE | KGO | 2004-09-16 |
| 186073 | 1314259465 | K041436 | SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 | KGO | 2004-08-20 |
| 216004 | 1284783191 | K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | MSH | 2002-07-23 |
| 235039 | 1356122521 | ||||
| 235039 | 1651111601 | ||||
| 216004 | 1970567853 | ||||
| 223090 | 1107251128 | ||||
| 341978 | 1650589237 | ||||
| 279136 | 1829243850 |
Product Codes Associated With Registrations#
NDC#
Zycubo
copper histidinate
Zokinvy
lonafarnib
Zokinvy
lonafarnib
Erythromycin
Erythromycin
Ciprofloxacin and dexamethasone
Ciprofloxacin and dexamethasone
Loteprednol Etabonate
Loteprednol Etabonate
Loteprednol Etabonate
Loteprednol Etabonate
Loteprednol Etabonate
Loteprednol Etabonate
Ketotifen Fumarate Ophthalmic Solution
Ketotifen Fumarate
Oxygen
Oxygen
PMN#
LuMon(TM) System
Sentec AG
Sentec Digital Monitoring System (SDMS) tCOM+
Sentec AG
TraumaGuard Intra-abdominal Pressure Sensing System
Sentinel Medical Technologies, LLC
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs
Sentienx Sdn Bhd
CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)
Sentiar, Inc.
Lp(a) Ultra
SENTINEL CH. SpA
Sentient Manufacturing Laser Fiber
Sentient Manufacturing LLC
TraumaGuard Intra-abdominal Pressure Sensing System
Sentinel Medical Technologies, LLC
SentEP
SentiAR, Inc
Albumin BCP
Sentinel CH. SpA
CRP Vario
Sentinel CH, Spa
CRP Vario
SENTINEL CH. SpA
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software Including V-CareNet
SENTEC AG
LARIAT RS Suture Delivery Device
SentreHEART, Inc.
LARIAT Sulture Delivery Device
SENTREHEART INC.
ACE CALIBRATOR
SENTINEL CH. SpA
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
SENTINEL MEDICAL, INC.
CKMB UDR ASSAY
SENTINEL CH. SpA
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
SENTINELLE MEDICAL, INC.
SENTICARE PILLSTATION
SENTICARE, INC.
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
SENTEC AG
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51
SENTINELLE MEDICAL, INC.
AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION
SENTINELLE MEDICAL, INC.
KAPPA LIGHT CHAINS
SENTINEL CH. SpA
LAMBDA LIGHT CHAINS
SENTINEL CH. SpA
LARIAT II SUTURE DELIVERY DEVICE
SENTREHEART INC.
FINDRWIRZ GUIDE WIRE SYSTEM
SENTREHEART INC.
SENTINEL PLASMAPROTEINS CAL 3X
SENTINEL CH. SpA
MULTIGENT CREATININE (ENZYMATIC) ASSAY
SENTINEL CH. SpA
OCCLUSION BALLOON CATHETER
SENTREHEART INC.
SENTEC DIGITAL MONITORING SYSTEM
SENTEC AG
SENTINEL LITHIUM ASSAY
SENTINEL CH SPA
MODIFICATION TO SENTINEL CLIN CHEM CAL
SENTINEL CH. SRL
AEGIS
SENTINELLE MEDICAL, INC.
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
SENTECH KOREA CORP.
TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT
SENTRA MEDICAL DEVICES, LLC
LARIAT LOOP APPLICATOR
SENTREHEART
BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
SENTECH KOREA CORP.
VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS
SENTINELLE MEDICAL, INC.
SENTINEL PANCREATIC AMYLASE
SENTINEL CH. SRL
Applications#
GUDID#
Contact Gel 2ml - The Contact Gel is required for proper CO2 gas conduction from the patient's skin to the SenTec TC Sensors. Every time a SenTec TC Sensor is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor membrane.
2019-03-08
Multi-Site Attachment Ring for mature/intact skin - Single use sensor application ring, recommended for adult, pediatric and neonatal patients with mature/intact skin
2019-01-29
V-STATS™ Installation CD - PC based software required a) to configure special (safety-relevant) settings of the SenTec Digital Monitor (SDM), b) to manage ‘SDM Parameters Settings’ and c) to download trend data from the internal memory of the SDM to a PC. It includes features to analyze and view the downloaded trend data. The V-STATS™ software includes the V-CareNeT™ Package, which enables remote monitoring and alarm surveillance for multiple SDMs being connected to the same network as the PC with V-STATS™.
2016-08-31
PSG Cable P - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
SenTec Digital Monitor (with activated PO2 channel) - Stand alone monitor with colour display for continuous non-invasive vital parameter monitoring, with integrated docking station for sensor storage and calibration.
2016-08-31
OxiVenT™ Sensor - Digital Sensor for non-invasive and continuous measurement of transcutaneous carbon dioxide and oxygen partial pressure as well as pulse oximetry. Suitable for adult, pediatric and neonatal patients.
2016-08-31
PSG Cable N - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable M - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG).
2018-11-12
PSG Cable L - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG).
2018-11-12
PSG Cable K - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable J - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable H - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable G - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable F - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable E - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable D - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable C - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable B - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable A - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
Staysite Adhesive - The Staysite Adhesive (SA-MAR), is an optional, single-use adhesive which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF if more secure attachment is required.
2016-08-31
V-Sign™ Sensor 2 - Digital Sensor for non-invasive and continuous measurement of transcutaneous carbon dioxide partial pressure and pulse oximetry. Suitable for adult, pediatric and neonatal patients.
2016-08-31
Membrane Changer Inserts - The Membrane Changer (MC-R) is a reloadable tool to change the membrane of SenTec TC Sensors. Prior reuse, the Membrane Changer (MC-R) must be reloaded with a new Membrane Changer Insert (MC-I). The MC-I is single-use
2016-08-31
Membrane Changer Set - The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC-R) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. To enable an economic and cost saving membrane change, the Membrane Changer after use can be reloaded with a new Membrane Changer Insert (MC-I). The memrane changer set contains the MC-R and inserts (MC-I) to reload.Membrane Changer Set [1 membrane changer, 1 insert]
2016-08-31
Neonatal Starter Set (without Service Gas) - Neonatal Starter Set (without Service Gas) contains:Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)Service Gas (GAS-0812)
2016-08-31
Neonatal Starter Set - Neonatal Starter Set contains:Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)Service Gas (GAS-0812)
2016-08-31
PSG-X - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
Standard Starter Set (without Service Gas) - Standard Starter Set (without Service Gas) contains:Ear Clips (EC-MI)Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)
2016-08-31
Multi-Site Attachment Ring for fragile/sensitive skin - MAR-SF is intended to attach SenTec TC Sensors to various measurement sites for patients with sensitive, fragile but intact skin.
2016-08-31
Multi-Site Attachment Ring for mature/intact skin - MAR-MI is intended to attach SenTec TC Sensors to various measurement sites for patients with mature, intact skin.
2016-08-31
Digital Sensor Adapter Cable, 750 cm - Adapter cable to connect SenTec TC Sensors to the SenTec Digital Monitor. The adapter cable is available in different lengths (XXX=150 cm, 250 cm, 750 cm).
2016-08-31
Digital Sensor Adapter Cable, 250 cm - Adapter cable to connect SenTec TC Sensors to the SenTec Digital Monitor. The adapter cable is available in different lengths (XXX=150 cm, 250 cm, 750 cm).
2016-08-31
Standard Starter Set - Standard Starter Set contains:Ear Clips (EC-MI)Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)Service Gas (GAS-0812)
2016-08-31
Membrane Changer (reloadable) / single unit - The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC-R) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. To enable an economic and cost saving membrane change, the Membrane Changer after use can be reloaded with a new Membrane Changer Insert (MC-I).
2016-08-31
Contact Gel - The Contact Gel is required for proper CO2 gas conduction from the patient’s skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor membrane.
2016-08-31
Service gas - The Service Gas is required for the calibration of the PCO2-part of SenTec TC Sensors. Depending on usage of the SDMS one Service Gas cylinder lasts for approx. 3 to 4 weeks.
2016-08-31
Ear Clip - The Ear Clip is required to attach SenTec TC Sensors to the patient’s earlobe. Suitable for patients with earlobes of sufficient size and mature, intact skin.
2016-08-31
Digital Sensor Adapter Cable, 150 cm - Adapter cable to connect SenTec TC Sensors to the SenTec Digital Monitor. The adapter cable is available in different lengths (XXX=150 cm, 250 cm, 750 cm).
2016-08-31
Sentec Digital Monitor - Stand alone monitor with colour display for continuous non-invasive vital parameter monitoring, with integrated docking station for sensor storage and calibration.
2016-08-31
Contact Gel - The Contact Gel is required for proper CO2 gas conduction from the patient's Skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor Membrane. GEL-SD is delivered in single dose vials each containing 0.3 g of the solution and is intended for single use.
2019-03-05
Membrane Changer (single-use) / single unit - The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. The MC is single-use.
2021-02-28