TENACORE OXYGEN BLENDER, MODEL TB-2000
TENACORE HOLDINGS, INC.
TENACORE LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008403701 | 3008403701 | TENACORE LLC | 1 | Y | 2026-01-01 | 3115 Airway Ave Costa Mesa CA US 92626 |
| 3004467400 | 3004467400 | TENACORE HOLDINGS, INC. | 1 | N | 2020-04-25 | 1525 E Edinger Ave SANTA ANA CA US 92705 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 23497 | 1128567526 | K993383 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B | DSI | 2000-02-03 |
| 23497 | 1944775429 | K992503 | SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES | BZR | 1999-08-10 |
| 23497 | 1931824917 | K982839 | CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 | MEA | 1998-11-02 |
| 23497 | 1800745732 | K962380 | OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) | EOQ | 1996-08-09 |
| 23497 | 1307468873 | K954351 | SERIES 50XM | HGM | 1996-03-08 |
| 23497 | 1226560605 | K950461 | WELCH ALLYN OPHTHALMOSCOPE | HLI | 1995-04-04 |
| 23497 | 1930248551 | K925982 | BMD AIR/OXYGEN BLENDER | BZR | 1993-10-07 |
| 23497 | 1282704211 | K903771 | HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE | DXN | 1991-02-19 |
| 23497 | 1848047915 | K903104 | CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR | CBQ | 1991-01-23 |
| 23497 | 1588171636 | K900618 | HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 | KNG | 1990-04-25 |
| 23497 | 1318134784 | K883038 | P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER | BZR | 1988-11-16 |
| 23497 | 1273433918 | K844403 | MODEL FORCE 2 ELECTROSURGICAL GENERATOR | GEI | 1985-02-20 |
| 23497 | 1918341665 | K171865 | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring | HGM | 2017-08-24 |
| 23497 | 1164307125 | K131364 | FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE | FBO | 2014-01-02 |
| 23497 | 2064143666 | K122439 | INTELLIVUE PATIENT MONITOR | MHX | 2012-08-29 |
| 23497 | 1926056816 | K112652 | SURESIGNS VS2+ -SURESIGNS VSI | DXN | 2011-10-11 |
| 23497 | 1212352768 | K110266 | MAC 5500 HD, MAC 3500 | DPS | 2011-04-29 |
| 23497 | 1959763567 | K093788 | INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION | MHX | 2010-03-08 |
| 23497 | 1553029500 | K091834 | PASSPORT V MONITOR, MODEL 0998-00-6100 | MHX | 2009-07-15 |
| 23497 | 1180584346 | K090556 | SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE | MHX | 2009-04-30 |
| 23497 | 1828554837 | K090285 | SONICAID FM820 AND FM830 ENCORE | HGM | 2009-07-15 |
| 23497 | 1728020872 | K090136 | STERIS CMAX XLT SURGICAL TABLE | FQO | 2009-03-20 |
| 23497 | 1624144439 | K081983 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 | MHX | 2008-08-22 |
| 23497 | 1099381955 | K081335 | TENACORE OXYGEN BLENDER, MODEL TB-2000 | BZR | 2008-11-14 |
| 23497 | 1531379600 | K071800 | PHILIPS AVALON FETAL MONITORS FM20 AND FM30 | HGM | 2007-09-27 |
| 23497 | 1711478411 | K071530 | KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM | EOQ | 2007-08-24 |
| 23497 | 1433591013 | K071073 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE | MHX | 2007-05-11 |
| 23497 | 1919685562 | K062137 | MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 | HGM | 2006-08-24 |
| 23497 | 1221620812 | K061605 | NEMIO XG, SAA-580A | IYN | 2006-06-22 |
| 23497 | 1262904011 | K053420 | TENACORE SP02 SENSORS | DQA | 2006-11-15 |
| 23497 | 1645910406 | K053204 | INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A | CCK | 2006-02-03 |
| 23497 | 1708800236 | K053168 | BIPAP FOCUS | MNS | 2006-01-04 |
| 23497 | 1280762210 | K052973 | IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K | FRN | 2007-01-25 |
| 23497 | 1841312779 | K050583 | MODEL 250 SERIES MATERNAL/FETAL MONITOR | HGM | 2005-06-21 |
| 23497 | 1270460153 | K043075 | TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING | HGM | 2005-08-18 |
| 288201 | 1687041268 | K043075 | TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING | HGM | 2005-08-18 |
| 23497 | 1402616243 | K041741 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN | MHX | 2004-07-21 |
| 23497 | 1272165616 | K040743 | MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM | BSZ | 2004-04-22 |
| 23497 | 1766177975 | K040458 | MODIFICATION TO DASH 3000/4000 PATIENT MONITOR | MHX | 2004-06-03 |
| 23497 | 1882028991 | K033988 | GOLDWAY UT4000A VITAL SIGNS MONITOR | MWI | 2004-02-25 |
| 23497 | 1929079621 | K031781 | DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES | MHX | 2003-06-25 |
| 23497 | 1230296098 | K020531 | PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B | MHX | 2002-03-20 |
| 23497 | 1833332711 | K002758 | AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A | DSI | 2001-02-22 |
| 23497 | 1461440988 | K001814 | DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES | CCK | 2000-08-23 |
| 23497 | 1973248887 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MHX | 10 | 2012-08-29 |
| HGM | 8 | 2017-08-24 |
| BZR | 4 | 2008-11-14 |
| DXN | 2 | 2011-10-11 |
| EOQ | 2 | 2007-08-24 |
| CCK | 2 | 2006-02-03 |
| DSI | 2 | 2001-02-22 |
| FBO | 1 | 2014-01-02 |
| DPS | 1 | 2011-04-29 |
| FQO | 1 | 2009-03-20 |
| FRN | 1 | 2007-01-25 |
| DQA | 1 | 2006-11-15 |
| IYN | 1 | 2006-06-22 |
| MNS | 1 | 2006-01-04 |
| BSZ | 1 | 2004-04-22 |
| MWI | 1 | 2004-02-25 |
| MEA | 1 | 1998-11-02 |
| HLI | 1 | 1995-04-04 |
| CBQ | 1 | 1991-01-23 |
| KNG | 1 | 1990-04-25 |
| GEI | 1 | 1985-02-20 |
PMN#
TENACORE SP02 SENSORS
TENACORE HOLDINGS, INC.
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
TENACORE HOLDINGS, INC.
GUDID#
Tenacore - HP/Philips 8040 TOCO W/HORSESHOE AND KNOB with 12 Pin Round Connector
2016-10-17
Tenacore - HP/Philips M1355A TOCO W/HORSESHOE AND KNOB with 12 Pin Round Connector
2016-09-29
Tenacore - Corometrics Nautilus TOCO for 116, 118, 120 series, 150, 170 series monitors W/KNOB
2016-10-17
Tenacore - Corometrics Nautilus TOCO for 116, 118, 120 series, 150, 170 series monitors W/WING
2016-10-17
Tenacore - Corometrics 2260 TOCO for 116, 118, 120 series monitors W/WINGS
2016-10-17
Tenacore - HP/Philips 8040 Ultrasound W/HORSESHOE AND KNOB
2016-09-29
Tenacore - Corometrics Nautilus Ultrasound for 116, 118, 120 series, 150, 170 series monitors W/KNOB
2016-10-18
Tenacore - Corometrics Nautilus Ultrasound for 116, 118, 120 series, 150, 170 series monitors W/WING 8′
2016-10-18
Tenacore - Corometrics Ultrasound for 116, 118, 120 series monitors W/WINGS 5700
2016-09-29
Tenacore - Corometrics Ultrasound for 115/145 monitors W/WINGS AND KNOB
2016-10-18
Veevo - Adult Intermittent Only
2016-09-29
Veevo - Adult Continuous Intermittent Wall Suction
2016-09-29
Tenacore - HP/Philips M1356A Ultrasound W/HORSESHOE AND KNOB
2016-10-18
Veevo - Adult Continuous Full Wall Suction
2016-09-29
Veevo - Adult Continuous Only Wall Suction Regulator
2016-09-29
Veevo - Surgical Continuous Full Wall Suction
2016-09-29
Veevo - Pediatric Continuous-Intermittent Vacuum Regulator
2016-09-29
Veevo - Pediatric Intermittent Only Wall Suction
2016-09-29
Veevo - Pediatric Continuous Only Wall Suction
2016-09-29
Tenacore - High-Low Flow Oxygen Blender
2015-09-24
Tenacore - Low flow Oxygen blender
2015-09-24
Mothership Wireless Transducers, Button Style - Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership Wireless Fetal Ultrasound Transducer, Button-Style, F1 Mothership Wireless Tocodynamometer Transducer, Button Style, and F1 Mothership Wireless Fetal Transducer Base Station.
2017-10-16
Mothership Wireless Fetal Ultrasound Transducer, Button-Style - F1
2017-10-16
Mothership Wireless Fetal Tocodynamometer Transducer, Button Style - F1
2017-10-16
Mothership Wireless Fetal Ultrasound Transducer, Loop Style - F1
2017-10-16
Mothership Wireless Fetal Tocodynamometer Transducer, Loop-Style - F1
2017-10-16
Mothership Wireless Fetal Transducer Base Station - F1
2017-10-16
Mothership Wireless Transducers, Loop Style - Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership Wireless Fetal Ultrasound Transducer, Loop-Style, F1 Mothership Wireless Tocodynamometer Transducer, Loop Style, and F1 Mothership Wireless Fetal Transducer Base Station.
2017-10-16