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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Welch Allyn Braun ThermoScan PRO 4000 Dock with Electronic Ear Thermometer for Connex 6000-Series Vital Signs Monitor; Nickel–Metal Hydride (#53020-0000) Battery
WELCH ALLYN, INC.
901054
In Commercial Distribution

  • 00732094024593 ()
04000-900

  • Medical equipment clinical data interfacing software
Welch Allyn Thermometer Kit including SureTemp Plus 690 Electronic Thermometer (One per Room) with 9.0 ft/2.7 m Cord and Braun ThermoScan PRO 4000 Electronic Ear Thermometer; 5 Alkaline AA Batteries Total
WELCH ALLYN, INC.
901054
Not in Commercial Distribution

  • 00732094024159 ()
04690-200

  • Medical equipment clinical data interfacing software
Temperature Parameter Module for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. The Temperature Module provides continuous body temperature readings at a variety of sites including skin, rectal, nasal, esophageal, arterial, and venous.
Philips Medizin Systeme Bƶblingen GmbH
Temperature Parameter Module
In Commercial Distribution

  • 00884838021082 ()
862291

  • Patient monitoring system module, temperature
ECG Cable, 3 Attached Lead, Snap, AAMI, 1O'
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094033601 ()
008-0880-00

  • Multiple vital physiological parameter monitoring system, clinical
Welch Allyn Oral Temperature Probe for SureTemp 678/679 Electronic Thermometers; 9.0 ft/2.7 m Cord
WELCH ALLYN, INC.
901113
In Commercial Distribution

  • 00732094026306 ()
02678-100

  • Ophthalmic/otologic diagnostic set
Welch Allyn Rectal Temperature Probe for SureTemp 678/679 Electronic Thermometers; 9.0 ft/2.7 m Cord
WELCH ALLYN, INC.
901113
In Commercial Distribution

  • 00732094026078 ()
02679-100

  • Ophthalmic/otologic diagnostic set
Cable 400TM;For Siemens Monitor Series SC
Covidien LP
502-0415A
In Commercial Distribution

  • 20884521842882 ()
  • 10884521842885 ()

  • Length: 10 Feet


  • Electrical-only medical device connection cable, reusable
Cable 400TM;For HP (TM) or Philips (TM) Monitors HP and Philips are trademarks of their respective owners.
Covidien LP
502-0411A
In Commercial Distribution

  • 20884521842875 ()
  • 10884521842878 ()

  • Length: 10 Feet


  • Electrical-only medical device connection cable, reusable
Cable 400TM;For use with 4070 Temperature Monitor
Covidien LP
502-0410A
In Commercial Distribution

  • 20884521842868 ()
  • 10884521842861 ()

  • Length: 10 Feet


  • Electrical-only medical device connection cable, reusable
Cable 400TM;For Siemens Monitor Series SC
Covidien LP
502-0405A
In Commercial Distribution

  • 20884521842851 ()
  • 10884521842854 ()

  • Length: 16 Feet


  • Electrical-only medical device connection cable, reusable
Cable 400TM;For HP (TM) or Philips (TM) Monitors HP and Philips are trademarks of their respective owners.
Covidien LP
502-0401A
In Commercial Distribution

  • 20884521842844 ()
  • 10884521842847 ()

  • Length: 16 Feet


  • Electrical-only medical device connection cable, reusable
Cable 400TM;For 4070 Temperature Monitor
Covidien LP
502-0400A
In Commercial Distribution

  • 20884521842837 ()
  • 10884521842830 ()

  • Length: 16 Feet


  • Electrical-only medical device connection cable, reusable
Cable 400TM
Covidien LP
502-0415A
In Commercial Distribution

  • 10884521706446 ()
  • 10884521169326 ()

  • Length: 10 Feet


  • Electrical-only medical device connection cable, reusable
Cable 400TM
Covidien LP
502-0411A
In Commercial Distribution

  • 10884521706439 ()
  • 10884521169319 ()

  • Length: 10 Feet


  • Electrical-only medical device connection cable, reusable
Cable 400TM For 4070 Temperature Monitor
Covidien LP
502-0410A
In Commercial Distribution

  • 10884521706422 ()
  • 10884521169302 ()

  • Length: 10 Feet


  • Electrical-only medical device connection cable, reusable
Cable 400TM;For Siemens Monitor Series SC
Covidien LP
502-0405A
In Commercial Distribution

  • 10884521706415 ()
  • 10884521169296 ()

  • Length: 16 Feet


  • Electrical-only medical device connection cable, reusable
Cable 400TM For HP or Philips Monitors HP and Philips are trademarks of their respective owners.
Covidien LP
502-0401A
In Commercial Distribution

  • 10884521706408 ()
  • 10884521169289 ()

  • Length: 16 Feet


  • Electrical-only medical device connection cable, reusable
Cable 400TM For 4070 Temperature Monitor
Covidien LP
502-0400A
In Commercial Distribution

  • 10884521706392 ()
  • 10884521169272 ()

  • Length: 16 Feet


  • Electrical-only medical device connection cable, reusable
rSO2 Preamplifier
Covidien LP
PMC71V-SF
In Commercial Distribution

  • 20884521845036 ()
  • 10884521845039 ()


  • Tissue saturation oximeter
  • Cerebral oximeter
GE CARESCAPE (TM) rSO2 - INVOS Parameter;For use with GE Patient Monitors
Covidien LP
PMC71V-GE
In Commercial Distribution

  • 10884521780729 ()


  • Tissue saturation oximeter
  • Cerebral oximeter
No Description
Silipos Holding LLC
3786
In Commercial Distribution

  • 00614464037863 ()


  • Skin treatment/dressing-supportive glove/mitten, reusable
No Description
Silipos Holding LLC
786
In Commercial Distribution

  • 00614464007866 ()


  • Skin treatment/dressing-supportive glove/mitten, reusable
FallGuard CordLess monitor with 2 Infra-Red Motion Sensor pad
Smart Caregiver Corporation
GPIR2-SYS
In Commercial Distribution

  • 00812293011706 ()


  • Nurse call system alarm
up&up 10ct Digital Ovulation Test
TARGET CORPORATION
Digital Ovulation Test
Not in Commercial Distribution

  • 10492450308626 ()
  • 00492450308629 ()
  • 00633472000102 ()


  • Natural conception assistance kit
Digital Ovulation Predictor - 7 Tests with Insert
WALGREEN CO.
Multi-Use Digital MidStream 6
In Commercial Distribution

  • 00748349000564 ()
  • 00311917215778 ()
  • 10311917215775 ()


  • Natural conception assistance kit
Digital Ovulation Predictor - 7 Tests with Insert
WALGREEN CO.
Multi-Use Digital MidStream 6
In Commercial Distribution

  • 10311917198870 ()
  • 00311917198873 ()
  • 00748349000564 ()

  • Height: 83 Millimeter


  • Natural conception assistance kit
The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use.
Equinox Biotech Co., Ltd.
RH-LH-B
Not in Commercial Distribution

  • 06938444980036 ()
RH-LH-B

  • Natural conception assistance kit
Exchange Select One Step Ovulation Predictor
SPD SWISS PRECISION DIAGNOSTICS GMBH
One Step Ovulation Predictor
Not in Commercial Distribution

  • 00614299396432 ()
  • 00633472000140 ()
  • 10614299396439 ()


  • Natural conception assistance kit
Clearblue Ovul Dig 30ct. US
SPD SWISS PRECISION DIAGNOSTICS GMBH
Digital Ovulation Test
In Commercial Distribution

  • 00633472602399 ()
  • 10633472602396 ()
  • 00633472000096 ()


  • Natural conception assistance kit
CB Birth Control Refill 15ct US
SPD SWISS PRECISION DIAGNOSTICS GMBH
Digital Ovulation Test
In Commercial Distribution

  • 10633472602389 ()
  • 00633472602382 ()
  • 00633472000096 ()
N/A

  • Natural conception assistance kit
A convenience kit consisting of 15 Digital Ovulation Tests, Digital Basal Thermometer and 3 month subscription to Natural Cycles app
SPD SWISS PRECISION DIAGNOSTICS GMBH
Birth Control Kit
In Commercial Distribution

  • 10633472602372 ()
  • 00633472602375 ()
N/A

  • Natural conception assistance kit
Clearblue Advanced Period Tracker 18ct
SPD SWISS PRECISION DIAGNOSTICS GMBH
Advanced Period Tracker
Not in Commercial Distribution

  • 10633472602099 ()
  • 00633472602092 ()
  • 00633472000096 ()


  • Natural conception assistance kit
CBCOT Ovulation Advanced 40ct
SPD SWISS PRECISION DIAGNOSTICS GMBH
Connected Ovulation Test System
Not in Commercial Distribution

  • 10633472601894 ()
  • 00633472601897 ()
  • 00633472000300 ()


  • Natural conception assistance kit
CBCOT Ovulation Advanced 25ct
SPD SWISS PRECISION DIAGNOSTICS GMBH
Connected Ovulation Test System
In Commercial Distribution

  • 10633472601207 ()
  • 00633472601200 ()
  • 00633472000300 ()


  • Natural conception assistance kit
CBDOT Clearblue Ovulation Digital 10ct Dual
SPD SWISS PRECISION DIAGNOSTICS GMBH
Digital Ovulation Test
In Commercial Distribution

  • 10633472600767 ()
  • 00633472600760 ()
  • 00633472000096 ()


  • Natural conception assistance kit
CBHOT Visual Ovulation Stick 5 Ct
SPD SWISS PRECISION DIAGNOSTICS GMBH
Easy Ovulation Test
In Commercial Distribution

  • 00633472600630 ()
  • 00633472000188 ()
  • 10633472600637 ()


  • Natural conception assistance kit
ADOT Clearblue Advanced Ovulation 10ct March of Dimes Dual US
SPD SWISS PRECISION DIAGNOSTICS GMBH
Advanced Digital Ovulation Test
Not in Commercial Distribution

  • 00633472600715 ()
  • 00633472600425 ()
  • 00633472000119 ()


  • Natural conception assistance kit
ADOT Clearblue Advanced Ovulation 20ct March of Dimes Dual US
SPD SWISS PRECISION DIAGNOSTICS GMBH
Advanced Digital Ovulation Test
Not in Commercial Distribution

  • 00633472600708 ()
  • 00633472600401 ()
  • 00633472000119 ()


  • Natural conception assistance kit
Clearblue Fertility Monitor with touch screen 1ct US
SPD SWISS PRECISION DIAGNOSTICS GMBH
Fertility Monitor
In Commercial Distribution

  • 10633472600224 ()
  • 00633472600227 ()


  • Natural conception assistance kit
Clearblue Digital Ovulation Test 20ct dual
SPD SWISS PRECISION DIAGNOSTICS GMBH
Digital Pregnancy Test
Not in Commercial Distribution

  • 10633472276894 ()
  • 00633472276897 ()
  • 00633472000096 ()


  • Natural conception assistance kit
Clearblue Fertility Monitor with touch screen fertility test sticks 30 ct
SPD SWISS PRECISION DIAGNOSTICS GMBH
Fertility Monitor Test Sticks
In Commercial Distribution

  • 00633472022258 ()
  • 00633472000256 ()
  • 10633472022255 ()


  • Natural conception assistance kit
AccuClear Ovul Strip 50ct US
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
OVULATION TEST
Not in Commercial Distribution

  • 10633472601955 ()
  • 00633472601958 ()
  • 00633472000393 ()


  • Natural conception assistance kit
Premom Semi-quantitative Ovulation Test; 20 LH strips; Kit
EASY HEALTHCARE CORPORATION
PMS2-S
In Commercial Distribution

  • 10850003180028 ()
  • 00850003180021 ()
  • 90850003180024 ()
PMS2-S-20

  • Natural conception assistance kit
Easy@Home Ovulation Test Kit; 80 LH strips + 20 HCG strips
EASY HEALTHCARE CORPORATION
EZW1-S; EZW2-S
In Commercial Distribution

  • 10850003180257 ()
  • 00850003180250 ()
  • 90850003180253 ()
EZ-WS8020

  • Natural conception assistance kit
5-Strip HCG Pregnancy Tests, 25-Strip LH-Ovulation Test, and 30 Plastic Urine Cups
VIVOSENS INC.
VWHL25V1
In Commercial Distribution

  • 10860011489167 ()
  • 00860011489160 ()
  • 20860011489164 ()


  • Natural conception assistance kit
Fertility Tracking Monitor
Lady Technologies, Inc.
K1
In Commercial Distribution

  • 00860003372906 ()


  • Natural conception assistance kit
Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home.
Mfb Fertility, Inc.
Confirm
In Commercial Distribution

  • 00860002790817 ()


  • Natural conception assistance kit
No Description
EASY HEALTHCARE CORPORATION
EZ-WS10020
In Commercial Distribution

  • 10850253007281 ()
  • 00850253007284 ()
  • 30850253007285 ()
EZW2-S, EZW1-S

  • Natural conception assistance kit
No Description
EASY HEALTHCARE CORPORATION
EZW2-S-50
In Commercial Distribution

  • 00850253007277 ()
  • 10850253007274 ()
  • 30850253007278 ()
EZW2-S

  • Natural conception assistance kit
No Description
EASY HEALTHCARE CORPORATION
EZW2-S-25
In Commercial Distribution

  • 00850253007260 ()
  • 10850253007267 ()
  • 30850253007261 ()
EZW2-S

  • Natural conception assistance kit
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