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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Mounting Bracket
Smart Caregiver Corporation
MB-01
In Commercial Distribution

  • 00812293014998 ()


  • Patient monitor remote control
Replacement Pull-String
Smart Caregiver Corporation
PS-01
In Commercial Distribution

  • 00812293014875 ()


  • Patient monitor remote control
Nurse Call Light Adaptor
Smart Caregiver Corporation
NCLA-12
In Commercial Distribution

  • 00812293014820 ()


  • Patient monitor remote control
Nurse Call Splitter
Smart Caregiver Corporation
NCS-02
In Commercial Distribution

  • 00812293013953 ()


  • Patient monitor remote control
Smart Light Outlet
Smart Caregiver Corporation
433-SO
In Commercial Distribution

  • 00812293013069 ()


  • Patient monitor remote control
Reset Magnet for Door Alarm
Smart Caregiver Corporation
CK-01D
In Commercial Distribution

  • 00812293010730 ()


  • Patient monitor remote control
Wireless Reset button
Smart Caregiver Corporation
433-RB
In Commercial Distribution

  • 00812293010549 ()


  • Patient monitor remote control
No Description
GE Healthcare Finland Oy
USB Remote Control
In Commercial Distribution

  • 00840682104449 ()


  • Patient monitor remote control
Remote Event Marker
Philips Medizin Systeme Bƶblingen GmbH
Remote Event Marker
In Commercial Distribution

  • 00884838009950 ()
989803143411

  • Patient monitor remote control
Remote Control
Philips Medizin Systeme Bƶblingen GmbH
865244
In Commercial Distribution

  • 00884838020740 ()
865244

  • Patient monitor remote control
ivWatch Patient Monitor, Model 400, English, Lease
IVWATCH, LLC
Model 400
In Commercial Distribution

  • 00814088020382 ()

  • Weight: 2.5 Pound
  • Depth: 2.63 Inch
  • Width: 6.14 Inch
  • Length: 8.0 Inch
00814088020382

  • Intravenous access site infiltration/extravasation monitoring system monitor
A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events
IVWATCH, LLC
Model 400
In Commercial Distribution

  • 00814088020092 ()

  • Weight: 2.5 Pound
  • Depth: 2.63 Inch
  • Width: 6.14 Inch
  • Length: 8.0 Inch
00814088020092

  • Intravenous access site infiltration/extravasation monitoring system monitor
A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events
IVWATCH, LLC
Model 400
In Commercial Distribution

  • 00814088020009 ()

  • Weight: 2.5 Pound
  • Depth: 2.63 Inch
  • Width: 6.14 Inch
  • Length: 8.0 Inch
00814088020009

  • Intravenous access site infiltration/extravasation monitoring system monitor
No Description
HELENA LABORATORIES CORPORATION
5757000
In Commercial Distribution

  • M52557570000 ()


  • Coagulation analyser IVD, laboratory
No Description
Levo Medical Corporation
Patient
In Commercial Distribution

60452

  • Tinnitus masking application software
No Description
OTOHARMONICS CORPORATION
PATIENT
In Commercial Distribution

  • B400215930 ()


  • Tinnitus masking application software
Infant Skin Temperature Probe, Single Patient Use (Giraffeā„¢, Pandaā„¢)
AIRLIFE
2074816-001
In Commercial Distribution

  • 20190752106144 ()
  • 10190752106147 ()
2074816-001

  • General-purpose patient temperature probe, single-use
Infant Skin Temperature Probe, Single Patient Use (Giraffeā„¢, Pandaā„¢)
AIRLIFE
2074817-001
In Commercial Distribution

  • 20190752106137 ()
  • 10190752106130 ()
  • 50190752106138 ()
2074817-001

  • General-purpose patient temperature probe, single-use
Infant Skin Temperature Probe, Single Patient Use, (Giraffeā„¢, Pandaā„¢)
Carefusion Finland 320 Oy
2074817-001
Not in Commercial Distribution

  • 20885403253697 ()
  • 70885403253692 ()
  • 10885403253690 ()
2074817-001

  • General-purpose patient temperature probe, single-use
Infant Skin Temperature Probe, Single Patient Use, (Giraffeā„¢, Pandaā„¢)
Carefusion Finland 320 Oy
2074816-001
Not in Commercial Distribution

  • 20885403253680 ()
  • 10885403253683 ()
2074816-001

  • General-purpose patient temperature probe, single-use
Digital oral Thermometer
FUTURE DIAGNOSTICS LLC
ET-110
In Commercial Distribution

  • 20370393421015 ()
  • 00370393421011 ()


  • General-purpose patient temperature probe, reusable
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Large
In Commercial Distribution

  • 05060488680069 ()
  • 05060488680298 ()
Lifetemp Sensor - V2 - Large

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Medium
In Commercial Distribution

  • 05060488680052 ()
  • 05060488680281 ()
Lifetemp Sensor - V2 - Medium

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Large
In Commercial Distribution

  • 05060488680045 ()
  • 05060488680274 ()
Lifetemp Sensor - V2 - Large

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - Large
In Commercial Distribution

  • 05060488680038 ()
Lifetemp Sensor - Large

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - Medium
In Commercial Distribution

  • 05060488680021 ()
Lifetemp Sensor - Medium

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - Small
In Commercial Distribution

  • 05060488680014 ()
Lifetemp Sensor - Small

  • Physiological measuring device wireless data capture/transfer unit
TIDI Thermometer Sheaths
TIDI PRODUCTS, LLC
20542
Not in Commercial Distribution

  • 00618125101726 ()
20542

  • Capillary thermometer cover
TIDI Thermometer Sheaths
TIDI PRODUCTS, LLC
20538
Not in Commercial Distribution

  • 00618125101719 ()
20538

  • Capillary thermometer cover
TIDI Thermometer Sheaths
TIDI PRODUCTS, LLC
20536
Not in Commercial Distribution

  • 00618125101696 ()
20536

  • Capillary thermometer cover
Digital Contactless Thermometer
NUVOMED, INC.
DCT-6/0894
In Commercial Distribution

  • 00859811008947 ()


  • General-purpose patient temperature probe, single-use
FDK DIGITAL THERMOMETER
Fudakang Industrial Inc.
BT-A41CN
In Commercial Distribution

  • 00859020006031 ()
  • 10859020006038 ()
  • 20859020006035 ()


  • General-purpose patient temperature probe, single-use
FDK DIGITAL THERMOMETER
Fudakang Industrial Inc.
BT-A11CN
In Commercial Distribution

  • 00859020006017 ()
  • 10859020006014 ()
  • 20859020006011 ()


  • General-purpose patient temperature probe, single-use
FDK DIGITAL THERMOMETER
Fudakang Industrial Inc.
BT-A13
In Commercial Distribution

  • 10859020006434 ()
  • 00859020006437 ()
  • 20859020006431 ()


  • General-purpose patient temperature probe, single-use
FDK DIGITAL THERMOMETER
Fudakang Industrial Inc.
BT-A31
In Commercial Distribution

  • 00859020006178 ()
  • 00859020006352 ()
  • 20859020006172 ()


  • General-purpose patient temperature probe, single-use
FDK DIGITAL THERMOMETER
Fudakang Industrial Inc.
BT-A21CN
In Commercial Distribution

  • 00859020006024 ()
  • 10859020006021 ()
  • 20859020006028 ()


  • General-purpose patient temperature probe, single-use
Oral Digital Thermometer
MOBI TECHNOLOGIES, INC.
70111
In Commercial Distribution

  • 10891040701111 ()
  • 00891040701114 ()
  • 20891040701118 ()


  • General-purpose patient temperature probe, single-use
Multi-Use Digital Thermometer
TOMY INTERNATIONAL, INC.
Y7078A7
In Commercial Distribution

  • B268Y7078A71 ()
  • B268Y7078A70 ()
  • B268Y7078A74 ()
  • B268Y7078A76 ()
Y7078A7

  • General-purpose patient temperature probe, reusable
Digital Thermometer, Rectal
SVS LLC
6806
In Commercial Distribution

  • 10818566016130 ()
  • 00818566016133 ()


  • General-purpose patient temperature probe, reusable
Digital Thermometer, Oral
SVS LLC
6805
In Commercial Distribution

  • 10818566016123 ()
  • 00818566016126 ()


  • General-purpose patient temperature probe, reusable
DISPOSABLE THERMOMETER,INTL
TELEFLEX INCORPORATED
IPN044433
In Commercial Distribution

  • 24026704390148 ()
  • 04026704390144 ()
41635

  • Respiratory gas thermometer
Disposable Thermometer Adaptor
TELEFLEX INCORPORATED
IPN042680
In Commercial Distribution

  • 24026704595024 ()
  • 04026704595020 ()
1645

  • Straight/elbow breathing circuit connector, single-use
Disposable Thermometer Adaptor
TELEFLEX INCORPORATED
IPN042680
In Commercial Distribution

  • 14026704595027 ()
  • 34026704595021 ()
1645

  • Straight/elbow breathing circuit connector, single-use
DISPOSABLE THERMOMETER,INTL
TELEFLEX INCORPORATED
IPN044433
In Commercial Distribution

  • 14026704390141 ()
  • 34026704390145 ()
41635

  • Respiratory gas thermometer
Disposable Thermometer Adaptor
TELEFLEX INCORPORATED
IPN913939
In Commercial Distribution

  • 24026704656770 ()
  • 14026704656773 ()
  • 34026704595021 ()
1645

  • Straight/elbow breathing circuit connector, single-use
Infrared lamp for therapeutic healing
ACCELERATED CARE PLUS CORP
76896
In Commercial Distribution

  • 00858703006061 ()
  • 10858703006068 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
64 LED Infrared Phototherapy Pad
HEALTHLIGHT LLC
HL-64R
In Commercial Distribution

  • 00858935006259 ()
502031

  • Musculoskeletal infrared phototherapy unit, non-wearable
64 LED Infrared Phototherapy System
HEALTHLIGHT LLC
HL-64-S
In Commercial Distribution

  • 00858935006242 ()
502030

  • Musculoskeletal infrared phototherapy unit, non-wearable
Boot Pad, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-BV
In Commercial Distribution

  • 00858935006075 ()
502007

  • Musculoskeletal infrared phototherapy unit, non-wearable
Face Mask, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-FM
In Commercial Distribution

  • 00858935006051 ()
502005

  • Musculoskeletal infrared phototherapy unit, non-wearable
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