Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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CABLE ASSY, TRUWAVE
Edwards Lifesciences LLC
896494023
In Commercial Distribution

  • 00690103218503 ()

  • Length: 162.0000 Inch
896494023

  • General-purpose patient temperature probe, reusable
CABLE ASSY,TRUWAVE,BI
Edwards Lifesciences LLC
896634004
In Commercial Distribution

  • 00690103218497 ()

  • Length: 162.0000 Inch
896634004

  • General-purpose patient temperature probe, reusable
CABLE ASSY, TRUWAVE, BI
Edwards Lifesciences LLC
896632004
In Commercial Distribution

  • 00690103218480 ()

  • Length: 162.0000 Inch
896632004

  • General-purpose patient temperature probe, reusable
CABLE ASSY,TRUWAVE, BI
Edwards Lifesciences LLC
896631004
In Commercial Distribution

  • 00690103218473 ()

  • Length: 162.0000 Inch
896631004

  • General-purpose patient temperature probe, reusable
CABLE ASSY,EW TRUWAVE
Edwards Lifesciences LLC
896622022
In Commercial Distribution

  • 00690103218466 ()

  • Length: 162.0000 Inch
896622022

  • General-purpose patient temperature probe, reusable
Cable Assy, EW 6 PIN/WK6
Edwards Lifesciences LLC
PX1800
In Commercial Distribution

  • 00690103218459 ()

  • Length: 162 Inch
896004025

  • General-purpose patient temperature probe, reusable
CABLE ASSY SIMPLE
Edwards Lifesciences LLC
896135022
In Commercial Distribution

  • 00690103218442 ()

  • Length: 162.0000 Inch
896135022

  • General-purpose patient temperature probe, reusable
CABLE ASSY, QUEST ANTEGRADE
Edwards Lifesciences LLC
896612022
In Commercial Distribution

  • 00690103218435 ()

  • Length: 162.0000 Inch
896612022

  • General-purpose patient temperature probe, reusable
896056023 CABLE ASSY,EW MARQUETTE/ROUND
Edwards Lifesciences LLC
896056023
In Commercial Distribution

  • 00690103218428 ()

  • Length: 162.0000 Inch
896056023

  • General-purpose patient temperature probe, reusable
896600022 CABLE ASSY,EW PRUCKA
Edwards Lifesciences LLC
896600022
In Commercial Distribution

  • 00690103218411 ()

  • Length: 162.0000 Inch
896600022

  • General-purpose patient temperature probe, reusable
CABLE ASSEMBLY,EW 6 PIN/MS3106
Edwards Lifesciences LLC
896025022
In Commercial Distribution

  • 00690103218404 ()

  • Length: 162.0000 Inch
896025022

  • General-purpose patient temperature probe, reusable
CABLE ASSY,TRUWAVE,TRI
Edwards Lifesciences LLC
896634005
In Commercial Distribution

  • 00690103218398 ()

  • Length: 162.0000 Inch
896634005

  • General-purpose patient temperature probe, reusable
CABLE ASSY,TRUWAVE,TRI
Edwards Lifesciences LLC
896631005
In Commercial Distribution

  • 00690103218381 ()

  • Length: 162.0000 Inch
896631005

  • General-purpose patient temperature probe, reusable
896633009 CABLE ASSY,EW,TRI,PHLPS
Edwards Lifesciences LLC
PX1800
In Commercial Distribution

  • 00690103218367 ()

  • Length: 162 Inch
896633009

  • General-purpose patient temperature probe, reusable
89663300 - CABLE ASSY,EW,BI,PHLPS
Edwards Lifesciences LLC
PX1800
In Commercial Distribution

  • 00690103218350 ()

  • Length: 162 Inch
896633008

  • General-purpose patient temperature probe, reusable
ATOM Disposable Skin Temp Probe BOX/20
Atom Medical Usa, LLC
NF-023T
In Commercial Distribution

  • 00860007476310 ()
  • 00860007476303 ()


  • General-purpose patient temperature probe, single-use
Truer Medical General Purpose Probes are designed for continuous temperature monitoring. Probes can be introduced through oral or rectal openings. Probes tips have special low-friction “frosted” finish to aid in the ease of placement and patient comfort.
TRUER MEDICAL, INC.
GP 14400
In Commercial Distribution

  • 00859290006120 ()
  • 40859290006128 ()
  • 30859290006121 ()
  • 20859290006124 ()
  • 10859290006127 ()
GP 14400

  • General-purpose patient temperature probe, single-use
Truer Medical General Purpose Probes are designed for continuous temperature monitoring. Probes can be introduced through oral or rectal openings. Probes tips have special low-friction “frosted” finish to aid in the ease of placement and patient comfort.
TRUER MEDICAL, INC.
GP 9400
In Commercial Distribution

  • 00859290006113 ()
  • 40859290006111 ()
  • 30859290006114 ()
  • 20859290006117 ()
  • 10859290006110 ()
GP 9400

  • General-purpose patient temperature probe, single-use
A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring system that are needed by the patient. A Health Harmony Hub Kit is for patients that do not use the Health Harmony Mobile application. (This is a viable option when the collection of vital signs alone provides adequate information for the clinician to remotely manage the patient.) The kit contains an interface hub device and any Bluetooth medical devices (e.g. a weight scale or a pulse oximeter) that have been selected by the healthcare provider for remote collection of patient vital signs.
Care Innovations, LLC
Kit RPM - Hub
Not in Commercial Distribution

  • 00850040853056 ()


  • Multiple physiological parameter spot-check system, home-use
A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring system that are needed by the patient. A Health Harmony BYOD Kit is for patients that download and use the Health Harmony Mobile application on their own personal mobile device. The kit will contain any Bluetooth medical devices (e.g. a weight scale or a pulse oximeter) that have been selected by the healthcare provider for remote collection of patient vital signs.
Care Innovations, LLC
Kit RPM - BYOD
Not in Commercial Distribution

  • 00850040853049 ()


  • Multiple physiological parameter spot-check system, home-use
A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring system that are needed by the patient. A Health Harmony Mobile Kit contains a personal mobile device pre-loaded with Health Harmony Mobile software that has been setup for the patient. The kit will also contain any Bluetooth medical devices (e.g. a weight scale or a pulse oximeter) that have been selected by the healthcare provider for remote collection of patient vital signs.
Care Innovations, LLC
Kit RPM - Mobile
Not in Commercial Distribution

  • 00850040853032 ()


  • Multiple physiological parameter spot-check system, home-use
Pediatric Tympanic Temperature Sensor (400 Series Thermistor)
STARBOARD MEDICAL, INC.
400-TYP
In Commercial Distribution

  • 10850933007105 ()
  • 00850933007108 ()
400-TYP

  • General-purpose patient temperature probe, single-use
Adult Tympanic Temperature Sensor (400 Series Thermistor)
STARBOARD MEDICAL, INC.
400-TY
In Commercial Distribution

  • 10850933007099 ()
  • 00850933007092 ()
400-TY

  • General-purpose patient temperature probe, single-use
Skin Temperature Sensor (400 Series Thermistor)
STARBOARD MEDICAL, INC.
400-SK
In Commercial Distribution

  • 10850933007082 ()
  • 00850933007085 ()
400-SK

  • General-purpose patient temperature probe, single-use
Esophageal/Rectal General Purpose 400 Series Temperature Sensor,12 Fr.
STARBOARD MEDICAL, INC.
40012-ER
In Commercial Distribution

  • 10850933007075 ()
  • 00850933007078 ()
40012-ER

  • General-purpose patient temperature probe, single-use
Esophageal/Rectal General Purpose 400 Series Temperature Sensor, 9 Fr.
STARBOARD MEDICAL, INC.
4009-ER
In Commercial Distribution

  • 10850933007068 ()
  • 00850933007061 ()
4009-ER

  • General-purpose patient temperature probe, single-use
TEMPERATURE MONITORING NEEDLE ELECTRODE
PMT CORPORATION
1952-2
In Commercial Distribution

  • 10650551046339 ()
  • 00650551046332 ()
1952-2

  • General-purpose patient temperature probe, single-use
TEMPERATURE MONITORING SURFACE/SUBSURFACE ELECTRODE
PMT CORPORATION
1952-1
In Commercial Distribution

  • 10650551046322 ()
  • 00650551046325 ()
1952-1

  • General-purpose patient temperature probe, single-use
No Description
FLEXICARE MEDICAL LIMITED
NF-024U
Not in Commercial Distribution

  • 00854401006327 ()


  • General-purpose patient temperature probe, reusable
No Description
FLEXICARE MEDICAL LIMITED
NF-023U
Not in Commercial Distribution

  • 00854401006310 ()


  • General-purpose patient temperature probe, single-use
D-208-700/FC100 Single Use Skin Temperature Probe
TARRY MEDICAL PRODUCTS, INC.
D-208-700/FC100
In Commercial Distribution

  • 10854758006206 ()
  • 00854758006209 ()
D208-700/FC100

  • General-purpose patient temperature probe, single-use
D-DP208-700HH Single Use Skin Temperature Probe
TARRY MEDICAL PRODUCTS, INC.
D-DP208-700HH
In Commercial Distribution

  • 10854758006190 ()
  • 00854758006193 ()
D-DP208-700HH

  • General-purpose patient temperature probe, single-use
D-DP697-700-HH Single Use Skin Temperature Probe
TARRY MEDICAL PRODUCTS, INC.
D-DP697-700-HH
Not in Commercial Distribution

  • 00854758006186 ()
  • 10854758006183 ()
D-DP697-700-HH

  • General-purpose patient temperature probe, single-use
D-209-20-HH Single Use Skin Temperature Probe
TARRY MEDICAL PRODUCTS, INC.
D-209-20-HH
In Commercial Distribution

  • 10854758006176 ()
  • 00854758006179 ()
D-209-20-HH

  • General-purpose patient temperature probe, single-use
T 08730P Single Use Skin Temperature Probe
TARRY MEDICAL PRODUCTS, INC.
T 08730P
Not in Commercial Distribution

  • 10854758006114 ()
  • 00854758006117 ()
T 08730P

  • General-purpose patient temperature probe, single-use
T 3000P Single Use Skin Temperature Probe
TARRY MEDICAL PRODUCTS, INC.
T 3000P
Not in Commercial Distribution

  • 00854758006100 ()
  • 10854758006107 ()
T 3000P

  • General-purpose patient temperature probe, single-use
T 20980 Reusable Use Air Temperature Probe
TARRY MEDICAL PRODUCTS, INC.
T 20980
Not in Commercial Distribution

  • 00854758006094 ()
T 20980

  • General-purpose patient temperature probe, reusable
T 97700 Reusable Use Skin Temperature Probe
TARRY MEDICAL PRODUCTS, INC.
T 97700
Not in Commercial Distribution

  • 00854758006087 ()
T 97700

  • General-purpose patient temperature probe, reusable
T 20970 Reusable Use Skin Temperature Probe
TARRY MEDICAL PRODUCTS, INC.
T 20970
Not in Commercial Distribution

  • 00854758006070 ()
T 20970

  • General-purpose patient temperature probe, reusable
T 11225 Reusable Use Skin Temperature Probe
TARRY MEDICAL PRODUCTS, INC.
T 11225
Not in Commercial Distribution

  • 00854758006063 ()
T 11225

  • General-purpose patient temperature probe, reusable
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