FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2
MEASUREMENT SPECIALTIES, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011369688 | 3011369688 | Measurement Specialties Chengdu | 1 | N | 2026-01-01 | No. 368 Wulian 1st Road Huangjia Street, Shuangliu District Chengdu Sichuan CN 610200 |
| 3012118599 | 3012118599 | Measurement Specialties Inc | 1 | Y | 2020-04-25 | 1711 139th Ln NW Andover MN US 55304 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| H29740091 | Tempheart - MEAS Tempheart® Shields | 800-899-9783 | medfeedback@te.com |
| H2974010 | Reusable GP Temperature Probe - Reusable Temperature Probe – Esophageal/Rectal (Adult) | 800-899-9783 | medfeedback@te.com |
| H29740100 | Extension Cable - 10’ Extension Cable (400 Series) | 800-899-9783 | medfeedback@te.com |
| H29744640 | MEAS 4400 Series Temperature Probe - Foley Catheter Temperature Probe, 14 FR | 800-899-9783 | medfeedback@te.com |
| H29744660 | MEAS 4400 Series Temperature Probe - Foley Catheter Temperature Probe, 16 FR | 800-899-9783 | medfeedback@te.com |
| H29744680 | MEAS 4400 Series Temperature Probe - Foley Catheter Temperature Probe, 18 FR | 800-899-9783 | medfeedback@te.com |
| H29780010634140 | 8001 Series Foley Catheter Temperature Probe - 8001 Series Foley Catheter Temperature Probe, 14 FR | 800-899-9783 | medfeedback@te.com |
| H29780010634160 | 8001 Series Foley Catheter Temperature Probe - 8001 Series Foley Catheter Temperature Probe, 16 FR | 800-899-9783 | medfeedback@te.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 185225 | 1357749694 | K971198 | BABYTHERM 8004 BABYTHERM 8010 | FMT | 1997-10-03 |
| 185225 | 1615641516 | K962070 | YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE | FLL | 1996-07-19 |
| 185225 | 1002354008 | K922007 | YSI MODEL 441A AIRWAY TEMPERATURE PROBE | BZT | 1992-11-04 |
| 185225 | 1841418517 | K921561 | YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES | EZL | 1992-11-23 |
| 185225 | 1408511233 | K893409 | YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP | BZT | 1989-07-20 |
| 185225 | 1582008889 | K883793 | DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS) | FLL | 1988-11-21 |
| 179175 | 1459790636 | K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso | DQA | 2016-08-05 |
| 185225 | 2010097376 | K160091 | Temperature Probe, Affinity Temperature Probe | FLL | 2016-05-20 |
| 179175 | 1311433211 | K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | MUD | 2015-04-10 |
| 179175 | 1249659946 | K132696 | TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR | DQA | 2013-09-27 |
| 179175 | 1998699220 | K132402 | SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM | DQA | 2014-02-21 |
| 185225 | 1421424793 | K121999 | GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE | FLL | 2013-02-28 |
| 179175 | 1012032631 | K103802 | TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR | DQA | 2011-08-02 |
| 179175 | 1869514482 | K102350 | PULSE OXIMETER | DQA | 2010-12-22 |
| 179175 | 1837779912 | K101871 | TRUSIGNAL SPO2 FINGERTIP SENSOR | DQA | 2010-10-04 |
| 185225 | 1210547202 | K100645 | AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE | DTZ | 2012-09-14 |
| 179175 | 1196431350 | K093881 | TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR | DQA | 2010-03-12 |
| 179175 | 1724599403 | K093853 | SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES | DQA | 2010-06-04 |
| 179175 | 1117759791 | K093306 | SINGLE-PATIENT USE DISPOSABLE SENSOR | DQA | 2010-03-04 |
| 179175 | 1185402386 | K080255 | NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER | DQA | 2008-05-23 |
| 185225 | 1390190113 | K063758 | CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R | BTT | 2007-04-23 |
| 185225 | 1126560223 | K050837 | REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE | FLL | 2005-04-27 |
| 179175 | 1529385083 | K040831 | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 | DPZ | 2004-09-02 |
| 185225 | 1282476535 | ||||
| 185225 | 1885045346 | ||||
| 179175 | 1012032631 | ||||
| 179175 | 1117759791 | ||||
| 179175 | 1132455937 | ||||
| 179175 | 1163617165 | ||||
| 179175 | 1185402386 | ||||
| 179175 | 1196431350 | ||||
| 179175 | 1249659946 | ||||
| 179175 | 1311433211 | ||||
| 179175 | 1355957232 | ||||
| 179175 | 1459790636 | ||||
| 179175 | 1529385083 | ||||
| 179175 | 1724599403 | ||||
| 179175 | 1837779912 | ||||
| 179175 | 1869514482 | ||||
| 179175 | 1998699220 |
MEASUREMENT SPECIALTIES, INC.
MEASUREMENT SPECIALTIES, INC.
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